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

Device Description

Sunmax Vietnam Co. Ltd Powder free Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05.

AI/ML Overview

The provided document describes the Sunmax Vietnam Co. Ltd Powder Free Nitrile Patient Examination Gloves and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria in the typical sense of a clinical trial for a diagnostic or therapeutic device. However, it does provide performance data against established ASTM standards for examination gloves.

Here's an analysis based on the information provided, framed to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements of ASTM D 6319-00a-05 for powder-free nitrile examination gloves. The document also compares the new device to several predicate devices.

Characteristic and Parameters	Acceptance Criteria (ASTM D 6319-00a-05 or Predicate Benchmark)	Reported Device Performance (Sunmax Vietnam Co., LTD Powder Free Nitrile Examination Glove)
Dermal Sensitization Test	Passes	Passes
Primary Skin Irritation	Passes	Passes
Permeation testing per ASTM D 6978-05	Passes (for chemical resistance, if tested specifically)	Passes
Iodine Test	Passes	Passes
Tensile strength	Meets requirements of ASTM D 6319-00a or comparable to predicates	Meets requirements of ASTM D6319-00a. (New Device: Pre-aging min 22, After-aging min 23.6)
Barrier strength (Pinholes)	AQL 2.5 (per ASTM D 6319-00a)	Meets requirements of ASTM D6319-00a.
Width (size medium)	89 mm (from predicate)	89 mm
Overall length	240 mm (from predicate)	240 mm
Palm thickness	Comparable to predicates (e.g., Min 0.08 mm, 0.109 mm)	0.12 mm
Finger thickness	Comparable to predicates (e.g., Min 0.08 mm, 0.148 mm)	0.12 mm
Ultimate elongation pre-aging min	Comparable to predicates (e.g., 510-679.4)	500
Ultimate elongation after aging	Comparable to predicates (e.g., 520-767.4)	500
Biocompatibility	Yes / Limited duration	Yes / Limited duration
Residual powder test	Passes	Passes

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

The document states that testing was conducted according to ASTM D 6319-00a-2005, which specifies sampling plans for physical properties and pinhole defects.

Sample Size: For physical specifications and dimensions, the inspection level S-2, AQL 4.0 is mentioned. For pinholes, AQL 2.5 is stated. ASTM D 6319-00a-2005 (Standard Specification for Nitrile Examination Gloves for Medical Application) outlines specific sampling plans based on lot size for these AQLs. For instance, for an Inspection Level S-2 and an AQL of 4.0, a sample size is drawn from the lot. The exact number of gloves tested is not explicitly stated but is implicitly defined by the ASTM standard for the given AQLs and inspection levels.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied that testing was performed by the manufacturer or a third-party lab according to the ASTM standard.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable in the context of this device. The "ground truth" here is objective physical and chemical testing against a recognized industry standard (ASTM D 6319-00a-2005). There are no human expert readings or interpretations required to establish ground truth for glove performance parameters like tensile strength, dimensions, or biocompatibility.

4. Adjudication Method for the Test Set

Not applicable. Testing involves objective measurements and pass/fail criteria based on ASTM standards, not expert adjudication.

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

No. This type of study (MRMC) is typically used for diagnostic devices involving human interpretation of images or other data. For patient examination gloves, the evaluation focuses on physical properties, barrier integrity, and biocompatibility, not human reader performance.

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

Not applicable. "Standalone" performance generally refers to the performance of an AI algorithm. This device is a physical medical device (gloves), not an AI system. The testing described is intrinsic to the device itself.

7. The Type of Ground Truth Used

The ground truth used consists of:

Established ASTM Standards: Specifically ASTM D 6319-00a-2005 requirements for physical properties (dimensions, tensile strength, ultimate elongation, barrier integrity).
Biocompatibility Testing: According to recognized protocols for dermal sensitization and primary skin irritation.
Permeation Testing: Per ASTM D 6978-05 (for resistance to permeation by chemotherapy drugs, if applicable, though the current device's predicate was tested for this, and the current device generally passes permeation testing).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." The manufacturing process for gloves is a continuous process, and quality control (QC) samples are taken periodically for testing. There isn't a "training set" in the machine learning sense.

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

Not applicable, as there is no "training set" for this type of device. Quality control and performance verification are established by adherence to manufacturing specifications and national/international standards.

Summary

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K101870

EXHIBIT #3

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

DEC 2 0 2010

Date: March 8, 2010 Updated: November 11, 2010

1. Applicant:

Sunmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

2. Manufacturer:

Sunmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

3. Submitter:

Mr. Jigar Shah Official Correspondent for Sunmax Vietnam Co. Ltd

4. Address:

mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com

5. Trade/proprietary Name:

Sunmax Vietnam Co. Ltd Powder free Nitrile Patient Examination Gloves.

Common Names: 6. POWDER-FREE Patient Examination Glove

1. Classification name: Patient Examination Glove
1. Classification number: 21 CFR 880.6250

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9. Device Description:

Sunmax Vietnam Co. Ltd Powder free Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05.

10. Intended Use:

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

11. Substantial Equivalence Discussion:

A powder free patient examination glove is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string is "K/01870". The characters are written in black ink on a white background. The handwriting is somewhat stylized.

Characteristicandparameters	SunmaxVietnamCo., LTDPowder FreeNitrileExaminationGlove(NewDevice)	SunmaxEnterpriseShanghaiCo., LTDPowder freeBlue NitrilePatientExaminationGlove testedwithchemotherapydrugs.(K090336)	ULTRAWINSDN BHDNon-SterilePowder FreeNitrileExaminationGloves(K 090828)	PT.MAHAKARYA INTIBUANAPowder FreeBlack NitrileExaminationgloves.(K090464)	SubstantiallyEquivalenceComparison
Product Code	LZA	LZA/LZC	LZA	LZA
Intended Use	A patientexaminationgloves is adisposabledeviceintended formedicalpurpose thatis wornon theexaminer'shand orfingers topreventcontaminationn betweenpatient andexaminer.	A patientexaminationgloves(Tested forUse withChemotherapy Drugs) is adisposabledeviceintended formedicalpurpose thatis worn on theexaminer'shand orfingers topreventcontaminationbetweenpatient andexaminer.	A patientexaminationgloves is adisposabledeviceintended formedicalpurpose thatis worn ontheexaminer'shand orfingers topreventcontaminationn betweenpatient andexaminer.	A powder-free patientexaminationglove is adisposabledeviceintended formedicalpurposes thatis worn ontheexaminer'shand orfinger topreventcontaminationn betweenpatient andexaminer.	SE
Width (sizemedium)	89	89	93-98	97.7	SE
Overall length	240	240	240	240.9	SE
Palm thickness	0.12	0.15	Min 0.08	0.109	MinorDifference
Fingerthickness	0.12	0.16	Min 0.08	0.148	MinorDifference
Tensilestrength preaging min	22	16.4	15 - 21	18.8	MinorDifference
Tensilestrength afteraging min	23.6	18.2	14-22	21.3	MinorDifference
Ultimateelongation preaging min	500	510	550-630	679.4	MinorDifference
Ultimateelongationafter aging	500	520	520-610	767.4	MinorDifference
MeetsBiocompatibility	yes	yes	Yes	Yes	SE
Duration ofbio-compatibility	Limited	Limited	Limited	Limited	SE
Skin irritationtest	Passes	Passes	Passes	Passes	SE
Dermalsensitization	Passes	Passes	Passes	Passes	SE
Residualpowder test	Passes	Passes	Passes	Passes	SE
Labeling	Guidancedocument"MedicalGloveGuidanceManual" hasbeenthoroughlyfollowedwith respectto Labelingof the device	SpecialtyMedicalGlovesLabeling	NA	NA	MinorDifferences

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KI01870

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1/01870

12. Summary of Testing:

Test	Results
a. Dermal Sensitization Test	Passes
b. Primary Skin irritation	Passes
c. Permeation testing per ASTM D 6978-05	Passes
d. Iodine Test	Passes
e. Tensile strength	Gloves meets the requirements ofASTM D63 19-00a.
f. Barrier strength	Gloves meets the requirements ofASTM D63 19-00a.

The standards used by Sunmax Vietnam Co. Ltd to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

There are no special labeling claims and we do not claim our gloves to be hypoallergenic.

13. Conclusion:

Powder free Nitrile Patient Examination Glove performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The seal is simple and monochromatic.

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

Sunmax Vietnam Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consulting, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

DEC 2 0 2000

Re: K101870

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 17, 2010 Received: November 19, 2010

Dear Mr. Shah:

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 provice
the Eaders! Found D 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: CDRF 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. Register. Begister .

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Page 2- Mr. Shah

Enclosure

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 potifice: ' on'' (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.

Nams J. Osorio D.

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

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EXHIBIT #1

Indications for Use

510(k) Number: K 101870

Applicant: Sunmax Vietnam Co. Ltd

DEC 2 0 2010

Device Name: Powder Free Nitrile Patient Examination Gloves.

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth S. Clameria Willer
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101870

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.