K Number

Device Name

NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE

Manufacturer

SGMP CO., LTD.

Date Cleared

2002-02-14

(15 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I nitrile patient examination glove 80LZA, powder free and meeting all the requirements of ASTM Class Finance partierd Specification for nitrile Examination Gloves for Medical Application, except for the elongation at break parameter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a medical glove and the description and performance studies focus on physical properties and biocompatibility, with no mention of AI/ML.

Therapeutic

No.
The device, a medical glove, is intended to prevent contamination between healthcare personnel and the patient, not to treat a disease, injury, or other medical condition.

Diagnostic

No
A medical glove is a barrier device to prevent contamination, not a device used to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device is a physical medical glove made of nitrile, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a medical glove worn on the hand to prevent contamination. This is a barrier device used externally.
Device Description: The description confirms it's a Class I nitrile patient examination glove. This type of device is not used for in vitro diagnostic purposes.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the core function of an IVD.
Performance Studies: The performance studies focus on physical properties (water tightness, biocompatibility, powder content) relevant to a barrier device, not diagnostic accuracy or analytical performance.

Therefore, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care and similar personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and results were within the ASTM D3578-00 requirements for exam gloves of 2.5% AQL.
Biocompatibility: The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.
Total Residual Powder Content & Presence of Cornstarch: Results for residual powder content (Range: 0.7-1.5mg/glove, Mean: 1.05 mg/glove) and presence of cornstarch (negative) meet FDA requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

FEB 14 2002

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE GREEN COLOR SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES

Contact person : Cheah Chor Hee

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Device Information:

Device Name - POWDER FREE GREEN COLOR SYNTHETIC POLYBUTADIENE COPOLYMER EXAM GLOVES

Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I latex patient examination glove 80LZA, powder free and meeting all Classinouncents of ASTM-D6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application.

Device Description:

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device:

1. Dimension

DIMENSION	ASTM D6319-00a	SGMP
X-Small	70 mm +/- 10 mm	70 - 75 mm
Small	80 mm +/- 10mm	80 - 85 mm
Medium	95 mm +/- 10mm	90 - 97 mm
Large	111mm +/- 10mm	105 - 111 mm
Length	230 mm minimum
for all sizes	242mm
Thickness - Finger	0.08mm min	0.08 mm min
Thickness - Palm	0.08mm min	0.08 mm min

	TENSILE STRENGTH
	ASTM
D 6319-00a	SGMP's	ASTM
D 6319-00a	SGMP's
Before Aging
X-Small
Small
Medium
Large	14.0
MPa	16.5
16.0
15.3
17.6
MPa	500
%	650
680
700
670
%
After Aging
X-Small
Small
Medium
Large	14.0	17.1
18.0
17.5
19.4	400	680
670
690
720

2. Physical Properties (ASTM-D6319-00a Standard Specification for Nitrile Exam Gloves) on Lot# Exp 02/01

3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:

| BATCH #
Exp | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| 02/01 | X-Small | 125 | Yes | 1 |
| 02/01 | Small | 125 | No | 0 |
| 02/01 | Medium | 125 | Yes | 2 |
| 02/01 | Large | 125 | Yes | 1 |
| AGED | | | | |
| 02/01 | X-Small | 125 | No | 0 |
| 02/01 | Small | 125 | Yes | 1 |
| 02/01 | Medium | 125 | Yes | 1 |
| 02/01 | Large | 125 | No | 0 |

The above figures are within the ASTM D3578-00 requirements for exam gloves of 2.5% AQL.

Biocompatibility 4.

The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.

5. Total Residual Powder Content & Presence of Cornstarch

| TESTS

REQUIREMENT	FDA	SGMP's
Residual Powder
Content
(ASTM D 6124-00)	2 mg/glove max	Range: 0.7-1.5mg/glove
Mean : 1.05 mg/glove
Presence of Cornstarch	Negative	Negative

Conclusion:-

The data presented indicate that the Powder Free Green Color Synthetic examination glove

meets/exceeds ASTM- D6319-00a Standard Specifications For nitrile Examination Glove,

1. meets FDA pinhole requirements,
1. meets FDA claim criterion of a powder free glove,

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

SGMP Company Limited C/O Ms. Janna Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434

Re: K020317

K020317
Trade/Device Name: Non-Sterile Powder Free Green "Barrier-Pro" Synthetic Butadiene Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 22, 2002 Received: January 30, 2001

Dear Ms. Tucker:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) presidentially equivalent (for the referenced above and have decemined the use its marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed profithe Medical Devic indications for use stated in the cholorate, we segment date of the Medical Device interstate commerce prior to May 20, 1970, also started in accordance with the provisions of Amendments, or to devices that have book for that do not require approval of a prematice the Federal Food, Drug, and Cosment Act (110) e. market the device, subject to the general
approval application (PMA). You may, therefore, softhe Aat include approval application (1 Mrx). Fou may strong provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice, requirements for anitations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) of class III If your device is classified (SCC above) into cantrols. Existing major regulations affecting (PMA), it may be subject to such additional controllar Stile 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, In the Federal your device can be found in the Code of Peacharding your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualled of a substance of a subscription with other requirements

Page 2 - Ms. Tucker

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and sugments, including, but not limited to: registration You must comply with an the Hecker & required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laseling (21 cms (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.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to begin mainting of substantial equivalence of your device to JTV(K) promatics nourieans - results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 IT you desire specific ac not 10- your for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Colliphance at (301) 89 . Intact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutication (21011111 art 00197).
the Act may be obtained from the Division of Small Manufacturers (1994) 1996 (197 the Act may be obtained in the enumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

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

INDICATIONS FOR USE STATEMENT

Applicant: SGMP CO LTD

...

KO20317 510K Number:

Device Name: Non-sterile Powder Free Green Color "Barrier-Pro" Synthetic Butadiene Copolymer Examination Gloves

Indications for Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ... ... ... Per 21 CFR 801.109

Over-The-Counter ... ... ... ... ...

Olin S. Lium

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __