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FDA 510(k)

LATEX EXAMINATION GLOVES-POWDER FREE

K-Number: K010356 · 2001-03-27

ApplicantEnzymic Technologies Sdn Bhd
Decision Date2001-03-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVES-POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Enzymic Technologies Sdn Bhd. It received FDA 510(k) clearance on 2001-03-27 under 510(k) number K010356. 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 LATEX EXAMINATION GLOVES-POWDER FREE?

LATEX EXAMINATION GLOVES-POWDER FREE is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Enzymic Technologies Sdn Bhd. The 510(k) number is K010356.

When did LATEX EXAMINATION GLOVES-POWDER FREE receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVES-POWDER FREE received FDA 510(k) clearance on 2001-03-27, under 510(k) number K010356.

Who is the listed applicant for LATEX EXAMINATION GLOVES-POWDER FREE?

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

What is the FDA product code for LATEX EXAMINATION GLOVES-POWDER FREE?

The FDA product code for LATEX EXAMINATION GLOVES-POWDER FREE is LYY.

Related Clinical Trials

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Other records listing Enzymic Technologies Sdn Bhd 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.

K010347LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE

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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