A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Device Description

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

AI/ML Overview

The provided 510(k) summary (K121528) describes the acceptance criteria and performance of Powder-Free Blue Nitrile Examination Gloves, Peppermint Scented. The study is a non-clinical performance assessment comparing the new device against established standards and a predicate device (K090194).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D6319-10	Meets
Physical Properties	ASTM D6319-10	Meets
Freedom from Pinholes	ASTM D6319-10 & FDA 21 CFR 800.20	Meets, AQL 2.5
Powder-Free	ASTM D 6124-06	Meets < 2mg/glove
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in Rabbits (Passes)	Passes (Not a primary skin irritant)
Biocompatibility: Dermal Sensitization	Dermal Sensitization (Passes)	Passes (Not a contact sensitizer)
Width (Medium)	Not explicitly stated as acceptance criteria, but compared to predicate (95 mm)	95 mm
Length	Not explicitly stated as acceptance criteria, but compared to predicate (240 mm)	240 mm
Single Palm Thickness	Not explicitly stated as acceptance criteria, but compared to predicate (0.09 mm)	0.09 mm
Single Finger Thickness	Not explicitly stated as acceptance criteria, but compared to predicate (0.10 mm)	0.10 mm
Single Cuff Thickness	Not explicitly stated as acceptance criteria, but compared to predicate (0.08 mm)	0.08 mm
Tensile strength pre-aging	Not explicitly stated as acceptance criteria, but compared to predicate (25 MPa, ASTM D412)	25 MPa
Tensile strength after aging	Not explicitly stated as acceptance criteria, but compared to predicate (25 MPa, ASTM D412)	25 MPa
Water Leak Testing	Not explicitly stated as acceptance criteria, but compared to predicate (AQL 2.5, ASTM D5151)	Water Leakage checked to AQL 2.5
Ultimate elongation pre-aging	Not explicitly stated as acceptance criteria, but compared to predicate (570%, ASTM D412)	592%
Ultimate elongation after aging	Not explicitly stated as acceptance criteria, but compared to predicate (577%, ASTM D412)	572%
Residual Powder	Not explicitly stated as acceptance criteria, but compared to predicate (< 2mg/glove, ASTM D6124)	< 2mg/glove

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only mentions that the device "Meets" the standards, implying that adequate samples were tested to demonstrate compliance.

The data provenance is retrospective and non-clinical. The testing was conducted on samples of the new device and compared against established ASTM standards and the characteristics of a predicate device. The origin of the data (country where tests were performed) is not specified, but the manufacturer is based in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a medical glove, and the acceptance criteria are based on objective, standardized physical and chemical tests (ASTM standards, FDA regulations), not on subjective expert interpretation of medical images or patient data. Therefore, "ground truth" as established by medical experts is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards, not on human interpretation requiring adjudication.

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

No. An MRMC study is not relevant for this type of device. This is a non-clinical performance evaluation of a glove, not an imaging diagnostic device or a device requiring human reader interpretation.

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

Not applicable. This device is not an algorithm or an AI-powered system. It is a physical medical device (examination glove). The performance described is its inherent physical and biological characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established consensus standards and regulatory requirements. Specifically:

ASTM International Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension).
FDA Regulations: Specifically, 21 CFR 800.20 ("Patient examination gloves").
Biocompatibility Testing Guidelines: Primary Skin Irritation and Dermal Sensitization tests are standard biological evaluation methods for medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is evaluated through physical and chemical testing of manufactured gloves.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The ground truth for the performance evaluation is established by the referenced ASTM and FDA standards and recognized biocompatibility testing methods.

Summary

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K12/528

33278 Central Ave., #102 Union City, CA 94587, USA T. 510.429.8692 F. 510.487.5347 TOLL FREE.1.888.988.8788

510(k) Summary

1.0 Submitter/ 510(k) Owner:

Name: Address: Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA. 94587

Phone No: 510-429-8692 Fax No: 510-487-5347

Manufacturer:

Name: ZHANGJIAGANG JIAMEI RUBBER PRODUCTS CO., LTD Address: FENGHUANG TOWN, ZHANGJIAGANG CITY, CHINA 215614

Phone No: 520-845-0023 Fax No: 520-845-0311

Date 510k Summary was prepared: August 7th, 2012

2.0 Contact Person:

Name:	Albert Li
Phone No:	510-429-8692
Fax No:	510-487-5347

3.0 Name of the device:

Trade Name:	Powder-Free Blue Nitrile Examination Gloves PeppermintScented
Device Name:	Powder-Free Blue Nitrile Examination Gloves PeppermintScented
Common Name:	Patient Examination Gloves
Classification Name:	Patient examination glove (21 CFR 880.6250, ProductCode FMC)
Product Code:	Nitrile -80LZA

Predicate Device Information: 4.0

Image /page/0/Picture/16 description: The image shows a logo for Shen Wei USA Inc. The logo features a black hand above the company name, with the words "PROMOTING YOUR SUCCESS!" underneath. The website address, www.shenweiusa.com, is also included at the bottom of the logo.

SEP 11 2012

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The predicate device is K090194, Powder-Free Nitrile Examination Gloves, Black Color, 07/07/2009. Class I Powder Free Nitrile Examination gloves, 80LZA, that meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20.

Description of The Device: 5.0

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

6.0 Labeling and Intended Use of the Device:

Draft labels for Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, can be found in Attachment 3.

The Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Indication for Use Statement can be found in Attachment 4.

7.0 Summary of the Technological Characteristics of the Device

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D6319-10	Meets
Physical Properties	ASTM D6319-10	Meets
Freedom from pinholes	ASTM D6319-10FDA 21 CFR 800.20	Meets, AQL 2.5
Powder-Free	ASTM D 6124-06	Meets < 2mg/glove
Biocompatibility	Primary Skin Irritation inRabbitsDermal Sensitization	Passes(Not a primary skin irritant)Passes (Not a contactsensitizer)

The test methods used are the same as those submitted in the original submission.

Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in section 7.0. A summary of the

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non-clinical performance data showing substantial equivalence to predicate device is presented in the table below:

Comparison with Predicate Device

CharacteristicandParameters	Powder-Free NitrileExamination Gloves, Blue withPeppermint Scent (NewDevice)	Powder-Free NitrileExamination Gloves, BlackColor (K090194 -Predicate)	SubstantialEquivalence(SE)
Product Code	80 LZA	80 LZA	SE
Color:	Blue	Black	SE
Compound:	Nitrile	Nitrile	SE
Labeling	See Attachment 2 (new)	See Attachment 2 (predicate)	SE
Intended Use	A disposable device intended formedical purpose that is worn onthe examiner's hand to preventcontamination between patientand examiner. This device issingle use only.	A disposable device intendedfor medical purpose that isworn on the examiner's handto prevent contaminationbetween patient and examiner.This device is single use only.	SE
Width(Medium)	95 mm	95 mm	SE
Length	240 mm	240 mm	SE
Single PalmThickness	0.09 mm	0.09 mm	SE
Single FingerThickness	0.10 mm	0.10 mm	SE
Single CuffThickness	0.08 mm	0.08 mm	SE
Tensilestrength pre-aging (ASTMD412)	25 MPa	25 MPa	SE
Tensilestrength afteraging (ASTMD412)	25 MPa	25 MPa	SE
Water LeakTesting (ASTMD5151)	Water Leakage checked to AQL2.5	Water Leakage checked to AQL2.5	SE
Ultimateelongationpre-aging(ASTM D412)	592%	570%	SE
Ultimateelongationafter aging(ASTM D412)	572%	577%	SE
Skin IrritationTest	Pass	Pass	SE
DermalSensitization	Pass	Pass	SE
ResidualPowder (ASTMD6124)	< 2mg/glove	< 2mg/glove	SE

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Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data is not needed for gloves.

10.0 Conclusion:

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, will perform according the glove performance standards referenced in section 7.0 above and meet ASTM standards, and FDA requirements for water leak.test on pinhole AQL. Also, this device is substantial equivalent in safety and performance to currently marketed devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Albert Li Director of Special Projects & Compliance Shen Wei USA. Incorporated 33278 Central Avenue, Suite 102 Union City, California 94587

EP 11 2012

Re: K121528

Trade/Device Name: Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA

Dated: July 20, 2012 Received: July 25, 2012

Dear Mr. Li:

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.

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Page 2- Mr. Li

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 device-related 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/CDRH/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For

Anthony D. Watson, BS, MS, MBA Director

Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI21528

Attachment Two

INDICATION FOR USE

Applicant: Shen Wei (USA) Inc.

Device Name: Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color

Indication For Use:

A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21CFR 801.109 OR

Over-The Counter X (Optional Format 1-2-96)

AD. But
m.D.

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

510(k) Number: K121528

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.