Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

K-Number: K170290 · 2017-05-24

ApplicantShen Wei USA, Inc.
Decision Date2017-05-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr 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 2017-05-24 under 510(k) number K170290. 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 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K170290.

When did Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr receive FDA 510(k) clearance?

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr received FDA 510(k) clearance on 2017-05-24, under 510(k) number K170290.

Who is the listed applicant for Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

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 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

The FDA product code for Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is LZA.

Related Clinical Trials

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.

NCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITINGNCT05989750Air-polishing With Erythritol During Orthodontic TretamentRECRUITINGNCT07624669A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy AdultsNOT_YET_RECRUITING

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

View all 19 devices →

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

View on FDA Database →

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

↑