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FDA 510(k)

COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE

K-Number: K001042 · 2000-05-23

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date2000-05-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE 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 2000-05-23 under 510(k) number K001042. 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 LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE?

COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K001042.

When did COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE receive FDA 510(k) clearance?

COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE received FDA 510(k) clearance on 2000-05-23, under 510(k) number K001042.

Who is the listed applicant for COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE?

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 LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE?

The FDA product code for COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE is LYY.

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Other records listing Comfort Rubber Gloves Industries Sdn. Bhd. as applicant

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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

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

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