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FDA 510(k)

Examination gloves -Type C (Nitrile gloves)

K-Number: K212290 · 2021-10-28

ApplicantJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Decision Date2021-10-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Examination gloves -Type C (Nitrile gloves) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K212290. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Examination gloves -Type C (Nitrile gloves)?

Examination gloves -Type C (Nitrile gloves) is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K212290.

When did Examination gloves -Type C (Nitrile gloves) receive FDA 510(k) clearance?

Examination gloves -Type C (Nitrile gloves) received FDA 510(k) clearance on 2021-10-28, under 510(k) number K212290.

Who is the listed applicant for Examination gloves -Type C (Nitrile gloves)?

The FDA 510(k) record lists Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Examination gloves -Type C (Nitrile gloves)?

The FDA product code for Examination gloves -Type C (Nitrile gloves) is LZA.

Other records listing Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214017Examination gloves-Type A(Latex gloves)K211953Disposable Sterilized Latex Surgical Gloves

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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