K Number

Device Name

NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Manufacturer

SGMP CO., LTD.

Date Cleared

2001-09-21

(28 days)

Product Code

LYY

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 latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.

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 description and performance studies focus on the physical properties and safety of a standard medical glove, with no mention of AI or ML.

Therapeutic

No
The device, a medical glove, is intended for barrier protection, not for treating or rehabilitating a disease or injury.

Diagnostic

No
The device is described as a medical glove intended to prevent contamination, which is a protective function rather than a diagnostic one.

SaMD (Software as a Medical Device)

The device is a physical medical glove made of latex, not a software application. The description focuses on material properties and physical performance tests.

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 to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a Class I latex patient examination glove. This is a physical barrier device.
Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on the physical properties of the glove (water tightness, biocompatibility, powder content, protein level), which are relevant to its function as a barrier, not as a diagnostic tool.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.

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 patient.

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.

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

LYY

Device Description

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.

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)

Dimension:
- X-Small: Length 252 mm, Finger Thickness 0.08 mm min, Palm Thickness 0.08 mm min
- Small: Length 252 mm, Finger Thickness 0.08 mm min, Palm Thickness 0.08 mm min
- Medium: Length 252 mm, Finger Thickness 0.08 mm min, Palm Thickness 0.08 mm min
- Large: Length 252 mm, Finger Thickness 0.08 mm min, Palm Thickness 0.08 mm min
Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1123:
- Before Aging:
  - X-Small: Tensile Strength 26.6 Mpa, Ultimate Elongation 870 %
  - Small: Tensile Strength 27.5 Mpa, Ultimate Elongation 870 %
  - Medium: Tensile Strength 23.2 Mpa, Ultimate Elongation 840 %
  - Large: Tensile Strength 25.7 Mpa, Ultimate Elongation 860 %
- After Aging:
  - X-Small: Tensile Strength 21.8 Mpa, Ultimate Elongation 870 %
  - Small: Tensile Strength 26.6 Mpa, Ultimate Elongation 950 %
  - Medium: Tensile Strength 23.7 Mpa, Ultimate Elongation 910 %
  - Large: Tensile Strength 24.4 Mpa, Ultimate Elongation 910 %
Water Tight Test (FDA specified 1,000 ml water leak test):
- Un-aged:
  - X-Small: Sample Size 125, Number Leaked 1
  - Small: Sample Size 125, Number Leaked 2
  - Medium: Sample Size 125, Number Leaked 0
  - Large: Sample Size 125, Number Leaked 2
- Aged:
  - X-Small: Sample Size 125, Number Leaked 0
  - Small: Sample Size 125, Number Leaked 1
  - Medium: Sample Size 125, Number Leaked 1
  - Large: Sample Size 125, Number Leaked 1
- Key Results: "The above figures are within the draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL."
Biocompatibility: "The bio-compatibility test results are as per attached in APPENDIX L and show that the gloves passed the tests for examination gloves."
Total Residual Powder Content & Presence of Cornstarch:
- Residual Powder Content (ASTM D 6124-00): Mean 1.2 mg/glove (Range: 0.8-1.6mg/glove), SGMP's REQUIREMENT 2 mg/glove max
- Presence of Cornstarch: Negative
Residual Protein Level: ASTM D 5712-99: Claimed Level

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

K012863

SEP 2 1 2001

APPENDIX M

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE VANILLA SCENTED LATEX 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:

Trade Name - NON-STERILE POWDER FREE VANILLA SCENTED LATEX EXAM GLOVES

Common Name - Exam gloves

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

Classification Information - Class I latex patient examination glove 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.

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:

DIMENSION	ASTM D3578-00	SGMP
X-Small
Small
Medium
Large	70 mm +/- 10 mm
80 mm +/- 10mm
95 mm +/- 10mm
111mm +/- 10mm	70 - 75 mm
80 - 85 mm
90 - 97 mm
105 - 111 mm
Length	230 mm minimum
for all sizes	252 mm
Thickness -
Finger
Palm	0.08mm min
0.08mm min	0.08 mm min
0.08 mm min

1. Dimension

	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-00	SGMP	ASTM-D3578-00	SGMP
Before Aging	Mpa	Mpa	%	%
14.0		700
X-Small		26.6		870
Small		27.5		870
Medium		23.2		840
Large		25.7		860
After Aging
14.0		500
X-Small		21.8		870
Small		26.6		950
Medium		23.7		910
Large		24.4		910

2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1123

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 #
1123 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | No | 0 |
| | Large | 125 | Yes | 2 |
| AGED | | | | |
| | X-Small | 125 | No | 0 |
| | Small | 125 | Yes | 1 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | Yes | 1 |

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

Biocompatibility 4.

The bio-compatibility test results are as per attached in APPENDIX L and show that the gloves passed the tests for examination gloves.

TESTS FDA INTERNAL SGMP's REQUIREMENT Range: 0.8-1.6mg/glove Residual Powder 2 mg/glove max Mean : 1.2 mg/glove Content (ASTM D 6124-00) Negative Presence of Cornstarch Negative

5. Total Residual Powder Content & Presence of Cornstarch

6. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-99