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FDA 510(k)

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

K-Number: K974424 · 1998-04-23

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date1998-04-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 1998-04-23 under 510(k) number K974424. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT RUBBER GLOVES INDUSTRIES SDN BHD?

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K974424.

When did COMFORT RUBBER GLOVES INDUSTRIES SDN BHD receive FDA 510(k) clearance?

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD received FDA 510(k) clearance on 1998-04-23, under 510(k) number K974424.

Who is the listed applicant for COMFORT RUBBER GLOVES INDUSTRIES SDN BHD?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT RUBBER GLOVES INDUSTRIES SDN BHD?

The FDA product code for COMFORT RUBBER GLOVES INDUSTRIES SDN BHD is LYY.

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Other records listing Comfort Rubber Gloves Industries 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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialK192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylK200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

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Related Devices (Code: LYY)

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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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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