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K Number
K052016
Device Name
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
Manufacturer
SGMP CO., LTD.
Date Cleared
2005-09-01

(37 days)

Product Code
LYY
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) 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
Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.
More Information

K011377, K011371

Not Found

No
The device is a standard patient examination glove, and the summary focuses on physical properties and testing standards, with no mention of AI or ML.

No.
The device description clearly states it is a glove for preventing contamination, not for treating any medical condition or disease.

No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, not to diagnose a condition.

No

The device is a physical product (gloves) and the description focuses on material properties and physical performance testing, not software functionality.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control.
  • Device Description: The description focuses on the physical properties and standards for examination gloves (ASTM-D3578-01aE2).
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
  • Performance Studies: The performance studies focus on physical properties, water tightness, biocompatibility, and powder/protein content – all relevant to a barrier device, not an IVD.

The information provided describes a standard medical glove, which is a Class I medical device used for protection, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) 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.

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

LYY

Device Description

Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care and similar personnel / Not Found

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)

The document describes several tests performed on the gloves to demonstrate their compliance with ASTM standards and FDA requirements:

  1. Dimension: Comparison of X-Small, Small, Medium, Large sizes and Length, Thickness (Finger and Palm) against ASTM D3578-01aE2 standards.
  2. Physical Properties: Tensile Strength (Mpa) and Ultimate Elongation (%) for X-Small, Small, Medium, and Large sizes, before and after aging, compared to ASTM-D3578-00aE2.
  3. Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size (X-Small, Small, Medium, Large) of both un-aged and aged gloves were tested. The leak status and number leaked were recorded. "The above figures are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL."
  4. Biocompatibility: "The bio-compatibility test results are as per attached in APPENDIX K and show that the gloves passed the tests for examination gloves." (Details not provided in the summary).
  5. Total Residual Powder Content & Presence of Cornstarch: Residual Powder Content (ASTM D 6124-00) measured in mg/glove compared against FDA requirement of 2 mg/glove max. Presence of Cornstarch tested for and found Negative.
  6. Residual Protein Level: Not found (table content is illegible).

Key results:

  • "meets/exceeds ASTM- D3578-00aE2 Standard Specifications For Latex Examination Glove"
  • "meets FDA pinhole requirements"
  • "meets FDA claim criterion of a powder free glove"
  • "meets the protein labelling claims level at

§ 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.

0

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K052016". The characters are written in a dark ink on a white background. The characters are all connected, and the string is slightly curved.

APPENDIX L

510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE MULTICOLOR LATEX EXAMINATION GLOVES

Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kanpaengpetch, Rattaphum, Songkhla 90180, Thailand.

  • Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emcrald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com
    Equivalent Predicate Device: POWDER FREE BLUE LATEX EXAM GLOVES which was granted a 510(k) # K011377 and POWDER-FREE PINK LATEX EXAM GLOVES which was also granted a 510 (k) # K011371 as shown in APPENDIX M

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

Device Information:

Trade Name - NON-STERILF POWDER FREE MULTICOLOR LATEX EXAMINATION 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-D3578-01aE2 Standard Specification for U.atex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes 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.

1

Technological Characteristics of Device:

1. Dimension

DIMENSIONASTM D3578-01aE2SGMP
X-Small70 mm +/- 10 mm70 – 80 mm
Small80 mm +/- 10 mm80 – 85 mm
Medium95 mm +/- 10 mm90 – 97 mm
Large111 mm +/- 10 mm105 - 111 mm
Length230 mm minimum
for all sizes242 mm
Thickness - Finger0.08 mm min0.13 mm min
Palm0.08 mm min0.1 mm min

2. Physical Properties (ASTM-D3578-00aE2 Standard Specification for Latex Exam Gloves) on Lot# 4144

TENSILE STRENGTHULTIMATE ELONGATION
ASTM-D3578-00aE2SGMPASTM-D378-00aE2SGMP
MpaMpa%%
Before Aging18.0650
X-Small23.5890
Small26.8800
Medium22.5850
Large29.2870
After Aging14.0500
X-Small22.8780
Small27.5820
Medium28.3750
Large26.8820

2

3. Water Tight Test

| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED
4144 | X-Small | 125 | No | 0 |
| 4144 | Small | 125 | Yes | 1 |
| 4144 | Medium | 125 | Yes | 2 |
| 4144 | Large | 125 | No | 0 |
| AGED
4144 | X-Small | 125 | No | 0 |
| 4144 | Small | 125 | Yes | 1 |
| 4144 | Medium | 125 | Yes | 1 |
| 4144 | Large | 125 | Yes | 2 |

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

The above figures are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL.

Biocompatibility 4.

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

5. Total Residual Powder Content & Presence of Cornstarch

| TEST | FDA
REQUIREMENT | INTERNAL SGMP's |
|---------------------------------------------|--------------------|--------------------------------------------------|
| Residual Powder Content
(ASTM D 6124-00) | 2 mg/glove max | Ranger: 0.4 - 1.0 mg/glove
Mean: 0.8 mg/glove |
| Presence of Cornstarch | Negative | Negative |

3

6. Residual Protein Level.

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Conclusion:-

The data presented indicate that the Non-sterile Powder Free Multicolor Latex Examination Gloves.

    1. meets/exceeds ASTM- D3578-00aE2 Standard Specifications For Latex Examination Glove,
    1. meets FDA pinhole requirements,
    1. meets FDA claim criterion of a powder free glove.
    1. meets the protein labelling claims level at