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FDA 510(k)

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K-Number: K092681 · 2010-02-23

ApplicantKhai Hoan Joint Stock Company
Decision Date2010-02-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Khai Hoan Joint Stock Company. It received FDA 510(k) clearance on 2010-02-23 under 510(k) number K092681. 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 POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is a medical device that received FDA 510(k) clearance on 2010-02-23. The listed applicant is Khai Hoan Joint Stock Company. The 510(k) number is K092681.

When did POWDERED LATEX EXAMINATION GLOVES, NON-STERILE receive FDA 510(k) clearance?

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE received FDA 510(k) clearance on 2010-02-23, under 510(k) number K092681.

Who is the listed applicant for POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

The FDA 510(k) record lists Khai Hoan Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

The FDA product code for POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is LYY.

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Other records listing Khai Hoan Joint Stock Company 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.

K113685POWDER FREE LATEX EXAMINATION GLOVES

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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