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FDA 510(k)

ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)

K-Number: K943566 · 1995-02-03

ApplicantWembley Rubber Products (M) Sdn Bhd
Decision Date1995-02-03
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) 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 1995-02-03 under 510(k) number K943566. 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 ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)?

ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K943566.

When did ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) receive FDA 510(k) clearance?

ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) received FDA 510(k) clearance on 1995-02-03, under 510(k) number K943566.

Who is the listed applicant for ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)?

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 ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)?

The FDA product code for ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) is KGO.

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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: 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

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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