Cleared Traditional

K152715 - HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

K152715 is an FDA 510(k) clearance for HAINING NITRILE POWDER FREE PATIENT EXA..., manufactured by Haining Medical Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K152715 · Haining Medical Products Co., Ltd. · General Hospital
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Feb 2016
Decision
157d
Days
Class 1
Risk

K152715 is an FDA 510(k) clearance for the HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Haining Medical Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on February 25, 2016 after a review of 157 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Haining Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K152715

510(k) Number K152715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date February 25, 2016
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 129d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - LZA Polymer Patient Examination Glove

All 1149
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K152715.
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
K152707 · Minghao Medical Products Co., Ltd. · Mar 2016
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
K152720 · Xingda Medical Products Co., Ltd. · Mar 2016
Nitrile Powder Free Patient Examination Gloves, Blue Color
K152712 · Zhonghong Pulin Medical Products Co., Ltd. · Mar 2016
Powder Free Nitrile Patient Examination Gloves, Blue Color
K151680 · Suqian Xingye Glove Co,Ltd · Feb 2016
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K152271 · Suqian Xingye Glove Co,Ltd · Feb 2016
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
K152542 · Riverstone Resources Sdn Bhd · Dec 2015