FDA 510(k)

ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)

K-Number: K946056 · 1995-07-20

ApplicantAmpri Rubberware Industries Sdn Bhd

Decision Date1995-07-20

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) is the device name listed in this FDA 510(k) record. The listed applicant is Ampri Rubberware Industries Sdn Bhd. It received FDA 510(k) clearance on 1995-07-20 under 510(k) number K946056. 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 ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)?

ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Ampri Rubberware Industries Sdn Bhd. The 510(k) number is K946056.

When did ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) receive FDA 510(k) clearance?

ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) received FDA 510(k) clearance on 1995-07-20, under 510(k) number K946056.

Who is the listed applicant for ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)?

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

What is the FDA product code for ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)?

The FDA product code for ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) is LYY.

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Other records listing Ampri Rubberware Industries Sdn Bhd as applicant

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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.