FDA 510(k)

NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)

K-Number: K925683 · 1993-06-04

ApplicantArista Latindo Industrial Ltd. P.T

Decision Date1993-06-04

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Arista Latindo Industrial Ltd. P.T. It received FDA 510(k) clearance on 1993-06-04 under 510(k) number K925683. 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 NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)?

NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) is a medical device that received FDA 510(k) clearance on 1993-06-04. The listed applicant is Arista Latindo Industrial Ltd. P.T. The 510(k) number is K925683.

When did NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) receive FDA 510(k) clearance?

NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) received FDA 510(k) clearance on 1993-06-04, under 510(k) number K925683.

Who is the listed applicant for NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)?

The FDA 510(k) record lists Arista Latindo Industrial Ltd. P.T as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)?

The FDA product code for NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) is LYY.

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Other records listing Arista Latindo Industrial Ltd. P.T 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.