FDA 510(k)

SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE

K-Number: K952556 · 1995-06-26

Decision Date1995-06-26

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Aladan Corp.. It received FDA 510(k) clearance on 1995-06-26 under 510(k) number K952556. 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 SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE?

SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1995-06-26. The listed applicant is Aladan Corp.. The 510(k) number is K952556.

When did SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1995-06-26, under 510(k) number K952556.

Who is the listed applicant for SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE?

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

What is the FDA product code for SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE?

The FDA product code for SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aladan Corp. as applicant

K960590TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE K952404SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE K943933SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM K951839ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES K943883SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM K942758HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE

View all 18 devices →

Related Devices (Code: LYY)

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 Limited K230573Powder 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 Bhd K223298Sterile 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.