LIFELINER SURGICAL GLOVE— 510(k) K910941

Substantially Equivalent

Depuy-Raynham

FDA 510(k) clearance K910941 for LIFELINER SURGICAL GLOVE, Substantially Equivalent on 1991-05-09. Applicant: Depuy-Raynham. Device class: 1.

Clearance details

Applicant: Depuy-Raynham
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1991-03-06
Decision date: 1991-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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
K910920 — PROTEKT GLOVES1991-05-15
K895667 — STERILE SURGICAL GOWN1989-10-13
K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS1989-09-19

More clearances from Depuy-Raynham

K914077 — REPEL(TM) LITE CUT RESISTANT GLOVE LINERS1991-12-02
K900310 — REPEL SURGICAL GLOVE LINERS1990-03-01

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