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FDA 510(k)

SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES

K-Number: K952155 · 1995-12-11

ApplicantWembley Rubber Products (M) Sdn Bhd
Decision Date1995-12-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K952155. 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 SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES?

SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K952155.

When did SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1995-12-11, under 510(k) number K952155.

Who is the listed applicant for SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES?

The FDA 510(k) record lists Wembley Rubber Products (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES?

The FDA product code for SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Wembley Rubber Products (M) Sdn Bhd 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.

K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)K972616ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)K953213COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)K962189COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

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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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

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