PATIENT PREP KITS/TRAYS-STERILE— 510(k) K821044

Name: FDA 510(k) clearance K821044
Creator: U.S. Food and Drug Administration
Published: 1982-06-23

Substantially Equivalent

Phoenix Glove Co.

FDA 510(k) clearance K821044 for PATIENT PREP KITS/TRAYS-STERILE, Substantially Equivalent on 1982-06-23. Applicant: Phoenix Glove Co.. Device class: 2.

Clearance details

Applicant: Phoenix Glove Co.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1982-04-14
Decision date: 1982-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Phoenix Glove Co.

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K830660 — STERILE SURGICAL DRAPES1983-03-17
K821666 — STERILE SURGICAL DRAPES1982-06-21
K821043 — STERILE PATIENT EXAM. GLOVES1982-05-21
K801846 — ELECTROCARDIOGRAPH ELECTRODE1980-09-09
K781820 — GLOVES, VINYL EXAMINATION1978-12-07

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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