LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE

• K Number: K123488
• Device Name: LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
• Manufacturer: PUYANG LINSHI HEALTH CO., LTD
• Date Cleared: 2013-02-08 ( 87 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K121947
• Predicate For: N/A

Intended Use

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Non-sterile, single-use, powder-free nitrile patient examination gloves (blue color), that meet requirements of ASTM D6139-10.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Linshi Health Nitrile Disposable Exam Gloves, Powder-Free, based on the provided 510(k) summary:

This device is a Class I medical device (patient examination glove), and the submission is for substantial equivalence to a predicate device (ETS Blue Powder Free Nitrile Patient Examination Glove K121947). For such devices, clinical studies and reader studies as typically understood for AI/ML devices are generally not applicable. Instead, the "study" involves demonstrating that the device meets established performance standards.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Subject Device)
Classification	Class I Patient Examination Glove
Product Code	LZA
Regulation	21 CFR 880.6250
Indications for Use	A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Description	Non-sterile, powder free, examination gloves made of nitrile and colored blue.
Packaging	Non-sterile gloves are provided in dispenser boxes.
Sterilization	Non-Sterile
Single Use	Yes
Ambidextrous	Yes
Dimensions	Meets ASTM D6319-10
Tensile Strength	Meets ASTM D6319-10
Ultimate Elongation	Meets ASTM D6319-10
Freedom from Pinholes	Meets ASTM D5151-06 and ASTM D6319-10
Residual Powder	Meets ASTM D6124-06
Biocompatibility	Passes Primary Skin Irritation in Rabbits; Passes Closed Patch Sensitization in Guinea Pigs

---

Study Details (as applicable for this type of device)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state a "test set" sample size in terms of clinical cases or images, as this is a physical medical device (gloves), not an AI/ML diagnostic or imaging device.
   • Instead, compliance is demonstrated by testing the physical properties of the gloves against established ASTM standards. The ASTM standards themselves specify sampling plans for testing. For example, ASTM D6319-10 (standard for Nitrile Examination Gloves for Medical Application) outlines sampling for tests like dimensions, tensile strength, elongation, and watertightness (pinholes).
   • Data Provenance: Not applicable in terms of country of origin for clinical data. The tests would likely be conducted in a laboratory setting, presumably by the manufacturer or a certified testing facility in China (country of manufacture). The ASTM standards are international benchmarks.
   • Retrospective or Prospective: Not applicable in the context of clinical studies. The testing is performed on manufactured lots of the product.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable. The "ground truth" for this device is defined by the objective, measurable parameters outlined in the ASTM standards (e.g., specific tensile strength in MPa, elongation percentage, maximum allowable number of pinholes per inspection level). These are not subjective interpretations requiring expert consensus.

3. Adjudication Method for the Test Set:

   • Not applicable. Performance is determined by objective laboratory measurements against set thresholds in ASTM standards, not by human adjudication of subjective assessments.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. This type of study is used to evaluate the impact of an AI system on human reader performance for diagnostic tasks. It is not relevant for the evaluation of disposable examination gloves.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No. This is a physical device, not an algorithm. Standalone performance as typically described for AI is not applicable.

6. The Type of Ground Truth Used:

   • The "ground truth" (or more accurately, the conformance standard) is established by objective, quantitative measurements against international consensus standards (ASTM). These standards define acceptable ranges for physical properties and biocompatibility.

7. The Sample Size for the Training Set:

   • Not applicable. There is no AI algorithm being trained for this device. The manufacturing process is designed to consistently produce gloves that meet the specified standards.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set as understood for AI/ML devices. The "ground truth" or target specifications for manufacturing are established by ASTM standards and validated through quality control testing.

Summary

{0}------------------------------------------------

5.0 510(k) Summary K123488

:

Submitter /Manufacturer /510(k) Owner:	Puyang Linshi Medical Supplies Co., Ltd. Industrial Park, Puyang County(East of Changsheng Road)Puyang City, 457100 Henan Province, China Telephone: [phone]Fax: [phone]Manufacturer Contact PersonMr. Frank Yanhai LvAssistant of the [e-mail]
ApplicationCorrespondent:	Ms. Laura WengVice President, [e-mail] Chemical America Co., Ltd.17800 Castleton St. Suite# 328City of Industry, CA 91748Telephone: [phone]Fax: [phone]
Date Prepared:	January 23, 2013
Trade Name:	Linshi Health Nitrile Disposable Exam Gloves, Powder-Free
CommonName:	Exam Gloves
Classification:	Class IPatient Examination Glove21 CFR 880.6250
Product Code:	LZA
PredicateDevice(s):	The subject device is equivalent to the following device:K121947ETS Blue Powder Free Nitrile Patient Examination Glove
DeviceDescription:	Non-sterile, single-use, powder-free nitrile patient examination gloves(blue color), that meet requirements of ASTM D6139-10.
Intended Use:	A powder-free patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's hand or finger toprevent contamination between patient and examiner.

{1}------------------------------------------------

mmary oftechnologicalLaracteristics	The powder-free blue nitrile examination glove is substantially equivaleto the predicate device with regard to physical characteristics, design,product features, and intended use.
	Feature	ETS Blue Powder FreeNitrile Exam GlovesK121947Predicate Device	Linshi Health NitrileDisposable Exam Gloves,Powder-FreeSubject Device
	Classification	Class IPatient Examination Glove	Same
	Product Code	LZA	Same
	Regulation	21 CFR 880.6250	Same
	Indications forUse	The examination glove is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner.	A powder-free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.
	Description	Non-sterile, powder free,examination gloves made ofnitrile and colored blue.	Same
	Packaging	Non-sterile gloves areprovided in dispenser boxes.	Same
	Sterilization	Non-Sterile	Same
	Single Use	Yes	Same
	Ambidextrous	Yes	Same
	Dimensions	Meets ASTM D6319-10	Same
	Tensile Strength	Meets ASTM D6319-10	Same
	UltimateElongation	Meets ASTM D6319-10	Same
	Freedom fromPinholes	Meets ASTM D5151-06 andASTM D6319-10	Same
	Residual Powder	Meets ASTM D6124-06	Same
	Biocompatibility	Passes Primary Skin Irritationin Rabbits	Same
		Passes Closed PatchSensitization in Guinea Pigs	Same

Puyang Linshi Health Co., Ltd. considers the Linshi Health Nitrile Conclusion: Disposable Exam Gloves, Powder-Free to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

Sum Tec Cha

K123488

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2013

Puyang Linshi Health Company, Limited C/O Ms. Laura Weng Vice President, Operations Linshi Chemical America Company, Limited 17800 Castleton Street, Suite 328 CITY OF INDUSTRY CA 91748

Re: K123488

Trade/Device Name: Powder-Free Nitrile Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: LZA Product Code: I Dated: January 23, 2013 Received: January 24, 2013

Dear Ms. Weng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Weng

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hor
The Harshitaid

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K123488

Indications for Use Statement 4.0

Device Name:

Powder-Free Nitrile Examination Gloves, Blue Color

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (21 CFR 801 Subpart D)

(

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Claverie

	2013.02.07 16:55:51 -05'00'
--	-----------------------------

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K123488
----------------	---------

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.