FDA 510(k)

SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE

K-Number: K952404 · 1995-07-20

Decision Date1995-07-20

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL 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 1995-07-20 under 510(k) number K952404. 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 HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE?

SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Aladan Corp.. The 510(k) number is K952404.

When did SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE receive FDA 510(k) clearance?

SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE received FDA 510(k) clearance on 1995-07-20, under 510(k) number K952404.

Who is the listed applicant for SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL 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 HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE?

The FDA product code for SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE is LYY.

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Other records listing Aladan Corp. as applicant

K960590TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE K952556SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION 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

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Related Devices (Code: LYY)

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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.