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FDA 510(k)

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX

K-Number: K022815 · 2003-02-13

ApplicantPt. Smartglove Indonesia
Decision Date2003-02-13
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Smartglove Indonesia. It received FDA 510(k) clearance on 2003-02-13 under 510(k) number K022815. 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 MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX?

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX is a medical device that received FDA 510(k) clearance on 2003-02-13. The listed applicant is Pt. Smartglove Indonesia. The 510(k) number is K022815.

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

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX received FDA 510(k) clearance on 2003-02-13, under 510(k) number K022815.

Who is the listed applicant for MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX?

The FDA 510(k) record lists Pt. Smartglove Indonesia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX?

The FDA product code for MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX is LYY.

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Other records listing Pt. Smartglove Indonesia 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.

K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUEK101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACKK041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLORK040792POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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