Cleared Traditional

K121998 - HM SURGICAL GOWN

K121998 is an FDA 510(k) clearance for HM SURGICAL GOWN, manufactured by Changzhou Holymed Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K121998 · Changzhou Holymed Products Co., Ltd. · General Hospital
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Dec 2012
Decision
164d
Days
Class 2
Risk

K121998 is an FDA 510(k) clearance for the HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGI.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Changzhou Holymed Products Co., Ltd. (Changhou, CN). The FDA issued a Cleared decision on December 20, 2012 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Changzhou Holymed Products Co., Ltd. devices

FDA 510(k) Submission Details - K121998

510(k) Number K121998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date December 20, 2012
Days to Decision 164 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 166
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