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FDA 510(k)

Examination gloves-Type A(Latex gloves)

K-Number: K214017 · 2022-07-14

ApplicantJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Decision Date2022-07-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Examination gloves-Type A(Latex gloves) is a medical device manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2022-07-14 under approval number K214017. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Examination gloves-Type A(Latex gloves)?

Examination gloves-Type A(Latex gloves) is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K214017.

When was Examination gloves-Type A(Latex gloves) approved by the FDA?

Examination gloves-Type A(Latex gloves) received FDA 510(k) clearance on 2022-07-14, under approval number K214017.

What company makes Examination gloves-Type A(Latex gloves)?

Examination gloves-Type A(Latex gloves) is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd..

What is the FDA product code for Examination gloves-Type A(Latex gloves)?

The FDA product code for Examination gloves-Type A(Latex gloves) is LYY.

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Other Devices by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K212290Examination gloves -Type C (Nitrile gloves) K211953Disposable Sterilized Latex Surgical Gloves

Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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