FDA 510(k)

DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES

K-Number: K974218 · 1997-12-18

Decision Date1997-12-18

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Perry. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K974218. 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 DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES?

DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Ansell Perry. The 510(k) number is K974218.

When did DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES receive FDA 510(k) clearance?

DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES received FDA 510(k) clearance on 1997-12-18, under 510(k) number K974218.

Who is the listed applicant for DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES?

The FDA 510(k) record lists Ansell Perry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES?

The FDA product code for DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES is LYY.

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Other records listing Ansell Perry as applicant

K003895X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 K002192DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 K001239ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K000165NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K993857THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR

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Related Devices (Code: LYY)

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 Limited K230573Powder 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 Bhd K223298Sterile 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.