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FDA 510(k)

LATEX EXAMINATION GLOVE POWDER FREE FORMTEX

K-Number: K931427 · 1993-10-15

ApplicantFormtex Medical Sdn. Bhd.
Decision Date1993-10-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE POWDER FREE FORMTEX is the device name listed in this FDA 510(k) record. The listed applicant is Formtex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K931427. 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 GLOVE POWDER FREE FORMTEX?

LATEX EXAMINATION GLOVE POWDER FREE FORMTEX is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Formtex Medical Sdn. Bhd.. The 510(k) number is K931427.

When did LATEX EXAMINATION GLOVE POWDER FREE FORMTEX receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE POWDER FREE FORMTEX received FDA 510(k) clearance on 1993-10-15, under 510(k) number K931427.

Who is the listed applicant for LATEX EXAMINATION GLOVE POWDER FREE FORMTEX?

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

What is the FDA product code for LATEX EXAMINATION GLOVE POWDER FREE FORMTEX?

The FDA product code for LATEX EXAMINATION GLOVE POWDER FREE FORMTEX 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 Formtex Medical 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.

K903857NON-STERILE LATEX DENTAL PROCEDURE GLOVESK900298GAMASHIELD

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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