isolation gown level-ii · 5/27/2020 · ocean freight forwarders, customs brokerage services,...

Isolation GownLevel-II

Private and confidential.

Presentation for the attention of McKesson only.

05/27/20

https://preparedus.com

CONTACT & ENQUIRIES ADDRESS

905 Westminster Ave, Unit AAlhambra, CA 91803

[email protected]+1 (626) 545 - 2990

2

This proposal shall provide the relevant information in order to

make decisions related to the procurement of Personal Protective

Equipment (PPE).

Prior to the outbreak of COVID-19, Prepared was one of the largest

clothing blank manufacturers in the market with substantial

industrial manufacturing capabilities in China.

Prepared is not a broker or intermediary, we directly manufacture

and distribute PPE.

Prepared has manufactured, sold and delivered over 60 million

face masks since 2/1/2020.

Executive Summary

When the retail clothing orders completely stopped in February,

we shifted all of our factory capacity to manufacturing PPE,

including KN95 masks, 3-ply masks, surgical gloves and gowns.

Due to our existing manufacturing and logistics capabilities prior

to COVID-19, we are incredibly well positioned to supply a large

quantity of PPE. The Principals of our firm have been in the soft

goods manufacturing and exporting business for 25 years.

Prepared currently has multiple factories in China running 24/7

and we are working to secure additional factory capacity in

Indonesia, Turkey, Sri Lanka, Mexico and China. We have nearly

100 quality control and logistics personnel working on the ground

in China, in addition to logistics teams in New Jersey and at our

Headquarters in Alhambra, California.

Prepared’s CAGE # is 8KE87 Prepared’s DUNS # is 115031892


mailto:sales%40preparedus.com?subject=Sales%20Order/Inquiry




[email protected]+1 (626) 545 - 2990

3Logistics Capabilities

Certainty of Execution

Prepared has extensive global logistics capabilities gained over

decades of soft goods manufacturing and exporting. Our existing

logistics infrastructure was extraordinarily well positioned to

transition to the manufacturing and delivery of PPE at the outset

of the pandemic.

Prepared has extensive worldwide relationships with Air and

Ocean Freight Forwarders, Customs Brokerage Services,

Warehousing / Distribution Companies, Trade Finance Companies

and Insurance Providers.

Our Logistics and Quality Control Team is on the ground in China

ensuring that our products are tested and certified to the most

up-to-date requirements by both the Chinese and US governments.

Our PPE products do not leave the factory floor until they have

been tested and certified compliant under SGS, ISO, CE, FDA, HHS

or other applicable standards.

We are working with multiple factories on the EUA approved list

of PPE manufactures, and others are undergoing certification.

Prepared’s Logistics Team is currently securing additional factory

capacity in China, Indonesia, Turkey, Sri Lanka and Mexico.

Prepared has significant internal financing capabilities in addition

to commitments from major Trade Finance Companies, such as

Challenger and Flexport.






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4

Material: 40 GSM Polypropylene

Non-Woven

Open Back

Adjustable Straps

AAMI: Level II

AATCC127: Hydrostatic Pressure >20

Size Range: Universal

Isolation Gowns – Level II

Product Spec






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5

Polybag: 38 x 31cm

Pcs/Polybag: 1x Gown/Polybag

Carton: 60 x 49 x 43cm

Pcs/Carton: 1000 pcs/carton

Medical Gowns

Packaging Details






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6Medical Gowns – Test Results

TESTING REPORT Report security check web: www.fcl-sz.org.cn Security code:0723854010

Report No. ZFLJ0495133 Page 1 of 3

Pronounce(声声明明): The results shown in this report refer only to sample(s) tested unless otherwise stated.(除非有其他说明，测试结果只对来样负责。) The test report cannot be reproduced, except in full.(本报告只能全部复制，不得部分复制。)

地址：江苏省苏州市吴江区盛泽镇敦煌路 3 88 号汇嬴金融大厦 1- 2 楼 h t t p : / / w w w. f c l - s z . o r g . c n

Floor 1-2,Huiying Financial Building,No.388,Dunhuang Road,Shengze,Wujiang,Suzhou,Jiangsu. Tel: +86 512 63081315 Fax: +86 512 63515926

苏苏州州中中纺纺联联检检验验技技术术服服务务有有限限公公司司

C N TA C Te s t i n g S e r v i c e C o . , L t d . ( S u z h o u )

Applicant Information (客客户户信信息息) Applicant Name(委托单位) : Suzhou Yatai textile Co., Ltd(苏州雅泰纺织有限公司) Contact person(委托人) : Tony

Sample Information (样样品品信信息息) Sample Description(样品描述) : One piece of blue composite fabric (一块蓝色复合面料) Style Name(品名) : 淋膜布 PP+PE 45GSM Sample Quantity(样品数量) : 50cm* Full width(整门幅) Colour(颜色) : Blue (蓝色)

- Sample receiving/Test started date (样品受理/检测起始日期) : 2020-05-08 - Report date (报告日期) : 2020-05-08 - The original sample is sticked on the last paper. (送检样品原样粘贴在本报告的末页)

Test Performed (检检验验标标准准) Judgement according to(评定依据):

The client requirement 客户要求 - Selected test(s) as requested by applicants. (本实验室根据客户要求完成以下检测内容)

Pronounce (声声明明) The results shown in this report refer only to sample(s) tested unless otherwise stated.All the items are performed in the standard conditions, except the noted cases.(除非特别说明，测试结果只对来样负责。所有测试项目均在标准规定的环境下进行，有注明除外。) Except for the requirement of the client, the test results and the conformity judgement of this report do not take the uncertainty of the test results into account.(除非客户要求，本报告检测结果及符合性判定不考虑测量结果的不确定度。)

Signed for and on behalf of CNTAC Testing Center-Suzhou

Approved by (批准)

Main testing by (主检)

Prepare by (制单)








--- Test Result (测测试试结结果果) ---

Test Result(测试结果) Requirements(评定条件) Judgement(判定)

1. Hydrostatic Pressure(静静水水压压) AATCC 127-2018 Distilled water temperature is 21℃. Test area:100cm2. The rate of increase of water pressure is 60mbar/min.Tested on face side.(测试水温：21℃，测试面积：100cm2，水压上升速率：60mbar/min，测试面：正面) Unit(单位): <cmH2O>

Result(测试结果) >20 ≥ 20 Pass(合格)








Original (送送检检样样品品原原样样)

======= End of Report (检测报告结束) ======

Hydrostatic Pressure Test






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7Medical Gowns – CertificationsISO Certification






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8Medical Gowns – Certifications

CCeerrttiiffiiccaattee ooff RReeggiissttrraattiioonn This certificate of Registration certifies that:

GARMENT 10 CORPORATION JOINT STOCK COMPANY

SAI DONG WARD ,LONG BIEN DIST., HA NOI, HA NOI, THANH PHO 100000 VIET NAM

has registered with the US Food and Drug Administration pursuant to Title 21 of the United States Code of Federal Regulations.

Owner Operator Number: 10071024

Listed Device

MSH D394399 Respirator, Surgical OEA D394397 Non-surgical isolation gown

US Agent: Willow Glen Consultancy LLC Willow Glen Number: WG2071039 Expiration Date: December 31, 2020

This certificate affirms that the above-named facility is registered with the US FDA pursuant to the regulations required by the US laws. This registration has been verified as effective by Willow Glen Consultancy as of the date below, unless such registration has been terminated after issuance of this Certificate. Willow Glen Consultancy makes no additional representations or warranties, nor does this certificate carry any to any person or entity other than the named certificate holder, for whose sole benefit it is issued. Willow Glen Consultancy assumes no liability to any person or entity in connection with the foregoing, nor does the U.S. FDA recognize a certificate of registration issued by Willow Glen Consultancy.

Willow Glen Consultancy is a private agent not affiliated with the U.S. Food and Drug Administration.

Amanda Ou, Operation Director WillowGlenFDA.com Willow Glen Consultancy LLC [email protected] +1-619-869-0249 3755 Avocado Blvd, Suite 208 Date: April 20, 2020 La Mesa, CA 91941, USA

GARMENT 10 CORRPORATION - JOINT STOCK COMPANY

Sai Dong Ward – Long Bien Dist – Ha Noi City – Vietnam

has submitted declaration of Conformity (Dated: 20-02-2020) according to

Class-1, Medical Devices Directive 93/42 EEC Annexure VII Organization has been assessed and found to be conforming with the requirements of the stated directive and

standards submitted through Declaration of conformity

Hence manufacturer places the CE marking with his own responsibility as follows:

For the Products of

3-Ply medical mask, 4-Ply medical mask, 3-Ply Surgical mask, 4-Ply Surgical mask,Antibacterial fabric Mask, N95 Mask, Protective cloth with hood & shoes cover

By QSA International, UK

Registration Number : QSA-20012292 Initial Certification Date: 17 March 2020 Certification Expiry Date: 16 March 2023

FDA Certificate of Registration CE Certificate of Registration




For More Information Please Contact:

James MansellExecutive Managing Director

Prepared

[email protected]


www.preparedus.com

CONTACT

mailto:James%40PreparedUS.com?subject=Prepared%20US%20-%20Sales%20order/inquiry



isolation gown level-ii · 5/27/2020 · ocean freight forwarders, customs brokerage services,...

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