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FDA 510(k)

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

K-Number: K162312 · 2017-07-25

ApplicantShen Wei USA, Inc.
Decision Date2017-07-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K162312. 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 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K162312.

When did Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color receive FDA 510(k) clearance?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color received FDA 510(k) clearance on 2017-07-25, under 510(k) number K162312.

Who is the listed applicant for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

The FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is LZA.

Other records listing Shen Wei USA, Inc. 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.

K213141Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionK213142Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid SolutionK213144Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsK211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)K211455Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White ColorsK202085Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

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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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