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FDA 510(k)

Disposable Sterilized Latex Surgical Gloves

K-Number: K211953 · 2022-05-25

ApplicantJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Decision Date2022-05-25
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Sterilized Latex Surgical 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 2022-05-25 under 510(k) number K211953. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Sterilized Latex Surgical Gloves?

Disposable Sterilized Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K211953.

When did Disposable Sterilized Latex Surgical Gloves receive FDA 510(k) clearance?

Disposable Sterilized Latex Surgical Gloves received FDA 510(k) clearance on 2022-05-25, under 510(k) number K211953.

Who is the listed applicant for Disposable Sterilized Latex Surgical 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 Disposable Sterilized Latex Surgical Gloves?

The FDA product code for Disposable Sterilized Latex Surgical Gloves is KGO.

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)K212290Examination gloves -Type C (Nitrile gloves)

Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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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