Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POWDERED LATEX EXAM GLOVES

K-Number: K941900 · 1994-06-21

ApplicantTg Medical Sdn. Bhd.
Decision Date1994-06-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Tg Medical Sdn. Bhd.. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K941900. 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 EXAM GLOVES?

POWDERED LATEX EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Tg Medical Sdn. Bhd.. The 510(k) number is K941900.

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

POWDERED LATEX EXAM GLOVES received FDA 510(k) clearance on 1994-06-21, under 510(k) number K941900.

Who is the listed applicant for POWDERED LATEX EXAM GLOVES?

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

What is the FDA product code for POWDERED LATEX EXAM GLOVES?

The FDA product code for POWDERED LATEX 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.

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 Tg 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.

K171276Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy DrugsK113393POWDER FREE BLACK NITRILE EXAMINATION GLOVESK993562POWDER FREE LATEX STERILE SURGICAL GLOVESK992841TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVESK992360TG MEDICAL POWDERED NITRILE EXAMINATION GLOVESK992219POWDERED LATEX STERILE SURGICAL GLOVES

View all 9 devices →

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.

↑