BOUFFANT CAP— 510(k) K972187

Substantially Equivalent

American Seal Co.

FDA 510(k) clearance K972187 for BOUFFANT CAP, Substantially Equivalent on 1997-09-09. Applicant: American Seal Co.. Device class: 2.

Clearance details

Applicant: American Seal Co.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-06-10
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from American Seal Co.

K972227 — SHOE COVER1997-09-09
K970814 — NON-STERILE ISOLATION GOWN1997-05-27
K964358 — AMSEAL SURGICAL FACE MASK1997-02-14
K892557 — MAYTEX NON-STERILE LATEX EXAM GLOVE1989-05-31
K892553 — MAYTEX PATIENT EXAMINATION GLOVES1989-05-25

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