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FDA 510(k)

PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)

K-Number: K970613 · 1997-03-18

ApplicantSti Medical Sdn Bhd
Decision Date1997-03-18
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Sti Medical Sdn Bhd. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K970613. 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 PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)?

PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Sti Medical Sdn Bhd. The 510(k) number is K970613.

When did PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970613.

Who is the listed applicant for PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)?

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

What is the FDA product code for PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)?

The FDA product code for PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sti Medical Sdn Bhd 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.

K962650PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)

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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