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FDA 510(k)

UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)

K-Number: K963211 · 1996-11-22

ApplicantAmerican Healthcare Products, Inc.
Decision Date1996-11-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Products, Inc.. It received FDA 510(k) clearance on 1996-11-22 under 510(k) number K963211. 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 UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)?

UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) is a medical device that received FDA 510(k) clearance on 1996-11-22. The listed applicant is American Healthcare Products, Inc.. The 510(k) number is K963211.

When did UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) receive FDA 510(k) clearance?

UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) received FDA 510(k) clearance on 1996-11-22, under 510(k) number K963211.

Who is the listed applicant for UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)?

The FDA 510(k) record lists American Healthcare Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)?

The FDA product code for UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) is LYY.

Related Clinical Trials

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.

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Other records listing American Healthcare Products, Inc. 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.

K062794PRN THERMALCARE, MODEL 3000

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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