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)

HYPOALLERGENIC LATEX GLOVES

K-Number: K924633 · 1993-01-27

ApplicantPan-Century Rubber Products Sdn. Bhd.
Decision Date1993-01-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPOALLERGENIC LATEX GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Pan-Century Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K924633. 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 HYPOALLERGENIC LATEX GLOVES?

HYPOALLERGENIC LATEX GLOVES is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Pan-Century Rubber Products Sdn. Bhd.. The 510(k) number is K924633.

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

HYPOALLERGENIC LATEX GLOVES received FDA 510(k) clearance on 1993-01-27, under 510(k) number K924633.

Who is the listed applicant for HYPOALLERGENIC LATEX GLOVES?

The FDA 510(k) record lists Pan-Century Rubber Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPOALLERGENIC LATEX GLOVES?

The FDA product code for HYPOALLERGENIC LATEX 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 Pan-Century Rubber Products 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.

K993183POWDER FREE GLOVES (POLYMER COATED)K993287POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK981164POWDER FREE CHLORINATED GLOVES-(TEXTURED)K955241HIGH RISK GLOVESK910047PATIENT EXAMINATION GLOVES-TEXTURED GLOVESK910045PATIENT EXAMINATION GLOVES-POWDER FREED

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.

↑