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FDA 510(k)

POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)

K-Number: K973811 · 1997-10-21

ApplicantAbsolute Quality Leadership, Inc.
Decision Date1997-10-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Absolute Quality Leadership, Inc.. It received FDA 510(k) clearance on 1997-10-21 under 510(k) number K973811. 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 POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)?

POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Absolute Quality Leadership, Inc.. The 510(k) number is K973811.

When did POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) receive FDA 510(k) clearance?

POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) received FDA 510(k) clearance on 1997-10-21, under 510(k) number K973811.

Who is the listed applicant for POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)?

The FDA 510(k) record lists Absolute Quality Leadership, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)?

The FDA product code for POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) is LYY.

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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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