FDA 510(k)

BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)

K-Number: K990540 · 1999-04-09

Decision Date1999-04-09

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 1999-04-09 under 510(k) number K990540. 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 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)?

BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K990540.

When did BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) receive FDA 510(k) clearance?

BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) received FDA 510(k) clearance on 1999-04-09, under 510(k) number K990540.

Who is the listed applicant for BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)?

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

What is the FDA product code for BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)?

The FDA product code for BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) is LYY.

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Other records listing Brightway Holdings Sdn. Bhd. as applicant

K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM K163267NITRILE EXAMINATION GLOVE K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

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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.