FDA 510(k)

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

K-Number: K010803 · 2001-05-11

Decision Date2001-05-11

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR 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 2001-05-11 under 510(k) number K010803. 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 POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR?

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Hwa Teh Industrial Sdn. Bhd.. The 510(k) number is K010803.

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

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR received FDA 510(k) clearance on 2001-05-11, under 510(k) number K010803.

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

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 POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR?

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

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

K000725HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)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.