Nitrile Examination Gloves

Polymer Patient Examination Glove

5R MED Instruments (Chengdu) Co., Ltd.

The following data is part of a premarket notification filed by 5r Med Instruments (chengdu) Co., Ltd. with the FDA for Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK210776
510k NumberK210776
Device Name:Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant 5R MED Instruments (Chengdu) Co., Ltd. Building 9, Section 1, No.618 Of West Kelin Road Chengdu,  CN 611130
ContactYuzhang Pan
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-07-12

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