PROTEKT GLOVES— 510(k) K910920

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K910920 for PROTEKT GLOVES, Substantially Equivalent on 1991-05-15. Applicant: Intermedics Orthopedics. Device class: 1.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1991-03-05
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Recent devices under product code FYE

K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN1994-04-11
K912790 — SURGICAL GOWN1991-09-19
K910941 — LIFELINER SURGICAL GLOVE1991-05-09
K895667 — STERILE SURGICAL GOWN1989-10-13
K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS1989-09-19

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K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.