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FDA 510(k)

Medical Examination Gloves (Tested for Use with Chemotherapy)

K-Number: K212506 · 2021-11-07

ApplicantGuangdong Gymda Medical Technology Co.,Ltd
Decision Date2021-11-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Examination Gloves (Tested for Use with Chemotherapy) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-11-07 under 510(k) number K212506. 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 Medical Examination Gloves (Tested for Use with Chemotherapy)?

Medical Examination Gloves (Tested for Use with Chemotherapy) is a medical device that received FDA 510(k) clearance on 2021-11-07. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. The 510(k) number is K212506.

When did Medical Examination Gloves (Tested for Use with Chemotherapy) receive FDA 510(k) clearance?

Medical Examination Gloves (Tested for Use with Chemotherapy) received FDA 510(k) clearance on 2021-11-07, under 510(k) number K212506.

Who is the listed applicant for Medical Examination Gloves (Tested for Use with Chemotherapy)?

The FDA 510(k) record lists Guangdong Gymda Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy)?

The FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy) is LZA.

Other records listing Guangdong Gymda Medical Technology 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.

K212078Medical Examination 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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