FDA 510(k)

POWDERED EXAMINATION GLOVES

K-Number: K930995 · 1993-08-16

Decision Date1993-08-16

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Healthcare Glovindo. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K930995. 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 EXAMINATION GLOVES?

POWDERED EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is P.T. Healthcare Glovindo. The 510(k) number is K930995.

When did POWDERED EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDERED EXAMINATION GLOVES received FDA 510(k) clearance on 1993-08-16, under 510(k) number K930995.

Who is the listed applicant for POWDERED EXAMINATION GLOVES?

The FDA 510(k) record lists P.T. Healthcare Glovindo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED EXAMINATION GLOVES?

The FDA product code for POWDERED EXAMINATION GLOVES is LYY.

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Other records listing P.T. Healthcare Glovindo as applicant

K021659PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)K010232PRE-POWDERED NITRILE EXAMINATION GLOVES K010233POWDER FREE NITRILE EXAMINATION GLOVES K000838DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K974853LATEX (POWDER FREE) LOW PROTEIN K931406POWDER-FREE PATIENT EXAMINATION GLOVES

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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.