Cleared Traditional

K802186 - DISPOSABLE NURSES CAP

K802186 is an FDA 510(k) clearance for DISPOSABLE NURSES CAP, manufactured by Anago, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802186 · Anago, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
16d
Days
Class 1
Risk

K802186 is an FDA 510(k) clearance for the DISPOSABLE NURSES CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Anago, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Anago, Inc. devices

FDA 510(k) Submission Details - K802186

510(k) Number K802186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date September 26, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FYF Cap, Surgical

All 9
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K802186.
BOUFFANT-STYLE SURGICAL CAP
K863359 · Kimberly-Clark Corp. · Sep 1986
BOUNDARY HEADWEAR
K831357 · Procter & Gamble Mfg. Co. · Jun 1983
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
CAP, CLARION NURSES, STYLE BOUFFANT 21
K770258 · Sherwood Medical Industries · Mar 1977
CAP, CLARION SURGEON'S
K770259 · Sherwood Medical Industries · Mar 1977
CAP, CLARION NURSES OR (TECHNIC)
K770260 · Sherwood Medical Industries · Mar 1977