FDA 510(k)

HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

K-Number: K000725 · 2000-04-05

Decision Date2000-04-05

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Hwa Teh Industrial Sdn. Bhd.. It received FDA 510(k) clearance on 2000-04-05 under 510(k) number K000725. 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 HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)?

HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) is a medical device that received FDA 510(k) clearance on 2000-04-05. The listed applicant is Hwa Teh Industrial Sdn. Bhd.. The 510(k) number is K000725.

When did HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) receive FDA 510(k) clearance?

HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) received FDA 510(k) clearance on 2000-04-05, under 510(k) number K000725.

Who is the listed applicant for HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)?

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

What is the FDA product code for HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)?

The FDA product code for HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) is LYY.

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Other records listing Hwa Teh Industrial Sdn. Bhd. as applicant

K010803POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR K994432HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)K992810HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE K992730HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE K896251HWA TEH EXAMINATION GLOVES

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.