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FDA 510(k)

POWDER-FREE EXAM GLOVES

K-Number: K970773 · 1997-12-04

ApplicantPt. Sarana Indoprotex
Decision Date1997-12-04
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Sarana Indoprotex. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K970773. 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 EXAM GLOVES?

POWDER-FREE EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Pt. Sarana Indoprotex. The 510(k) number is K970773.

When did POWDER-FREE EXAM GLOVES receive FDA 510(k) clearance?

POWDER-FREE EXAM GLOVES received FDA 510(k) clearance on 1997-12-04, under 510(k) number K970773.

Who is the listed applicant for POWDER-FREE EXAM GLOVES?

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

What is the FDA product code for POWDER-FREE EXAM GLOVES?

The FDA product code for POWDER-FREE EXAM GLOVES is LYY.

Related Clinical Trials

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.

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Other records listing Pt. Sarana Indoprotex 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.

K980605LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)K950823ANDALK913531PATIENT EXAMINATION GLOVEWS

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

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