letter of conformance - seeda glove · 2020. 11. 10. · products report no.: 60393368-001 page 1...
TRANSCRIPT
Form 818 R2
Page 1 of 1
LETTER OF CONFORMANCE TK Hitech Technology Co., Ltd. 1/221 Venish Iris Watcharaphol Road, Tha Rang, Bang Khen, Bangkok 10220 Thailand 29 June 2020 Dear Khun Dhonticha Bhakdidhanatkul, Further to your ongoing business by ISO9001:2015 & ISO14001:2015 & ISO13485:2016 certificate requested, BSI Group (Thailand) Co., Ltd. pleased to confirm that your Quality Management system, Environmental Management system and Medical Device Management system are in progress of assessment The approval is confirm on certification scope: The Manufacture and distribution of examination and industrial gloves. by initial assessment scheme. Regards,
Bookkhalakorn Chaidee (Mr.) General Manager of Sales and Marketing MB: 0865324271 Email : [email protected]
TK HITECH TECHNOLO
GY CO.,L
TD.
Acknowledgment Letter
8/24/2020
Joyce Kwon, CEOProvision Consulting Group Inc.100 N. Barrangca St.West Covina, CA 91791UNITED STATES
Dear Joyce Kwon:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has received your submission. This submission has been assigned the unique document control number below. All future correspondence regarding this submission should be identifiedprominently with the number assigned and should be submitted to the Document Control Center at the above letterhead address. Failure to do so may result in processing delays. If you believe the information identified below is incorrect, please contact the Office of Product Evaluation and Quality (OPEQ) submission support at (301) 796-5640 or [email protected].
Submission Number: K202419Received: 8/24/2020Applicant: TK Hitech Technology Co., Ltd.Device: BIOTECH Nitrile Examination Gloves
We will notify you when the review of this document has been completed or if any additional information is required. For information about CDRH review regulations and policies, please refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm .
Sincerely yours,
Center for Devices and Radiological Health
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
TK HITECH TECHNOLO
GY CO.,L
TD.
Products
Report No.: 60393368-001 Page 1 of 11
Client: TK Hitech Technology Co.,Ltd.
Contact Information: 1/221 Soi Watcharaphon 2/7, Tha Raeng, Bangkhen, Bangkok 10220, Thailand.
Identification / Model No(s): Nitrile Glove
Sample Receiving date: 2020-06-11
Testing Period: 2020-06-11 to 2020-07-02
Reference Order No.: 242121264
Delivery condition: Apparent good, Samples tested as received
Test Specification: Test result:
1. EN 455-1: 2000: Requirements for freedom from holes PASS
2. EN 455-2: 2015: Physical properties test;
- Dimension test PASS
- Force at break test PASS
3. EN 455-3: 2015 (E), Annex A : Proteins extraction by aqueous Refer to result page
4. US FDA 21 CFR 177.2600 (Rubber Articles) - Determination of Amount of Extractives PASS
Other Information:
Grade: MEDICAL GRADE
Manufacture: TK HITECH TECHNOLOGY CO., LTD.
Country of Origin: THAILAND
For and on behalf of TÜV
Rheinland Thailand Ltd.
TK HITECH TECHNOLO
GY CO.,L
TD.
