K Number
K072403
Device Name
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
Manufacturer
Date Cleared
2008-03-27

(213 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 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 meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
More Information

Not Found

No
The summary describes standard latex examination gloves and does not mention any AI or ML capabilities.

No.
The device, a latex examination glove, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a condition.

No.
The document describes protective gloves intended to prevent contamination, not to diagnose a condition or disease.

No

The device is a physical examination glove, which is a hardware medical device, not software. The summary describes physical properties and performance studies related to the material and construction of the glove.

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 patient and examiner" by being worn on the hand or finger. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
  • Device Description: It is described as a "Class I latex patient examination glove." Examination gloves are typically considered medical devices, but not IVDs.
  • Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
  • Performance Studies: The performance studies focus on physical properties, barrier integrity, and biocompatibility, which are relevant to a protective barrier device, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any such function.

N/A

Intended Use / Indications for Use

The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 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 meeting all the requirements of ASTM-D3578-05 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 or finger

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. Results showed that for UN-AGED gloves, Number Leaked were 2 for X-Small, 2 for Small, 1 for Medium, and 2 for Large. For AGED gloves, Number Leaked were 0 for X-Small, 3 for Small, 2 for Medium, and 1 for Large. The figures are within the ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.

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

Total Residual Powder Content & Presence of Cornstarch (ASTM D 6124-06): The internal SGMP'S range was 5.2 - 8.5 mg/ dm² with a mean of 7.5 mg / dm², which is below the FDA Requirement of 10 mg/ dm² max.

Residual Protein Level (ASTM D 5712-99): The claimed level was

§ 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.

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APPENDIX I

K072403

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDERED PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND WITH PROTEIN LABELING CLAIMS (200 MICROGRAMS OR LESS)

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

Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com

Equivalent Predicate Device: POWDERED PINK LATEX EXAM GLOVES which was granted a 510(k) # K000671

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

Device Information:

Trade Name - Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (200 Micrograms or less)

Common Name - Exam gloves

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

Classification Information - Class I Latex patient examination glove 80LYY, powdered and meeting all the requirements of ASTM-D3578-05 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-D3578-05 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.

1

Technological Characteristics of Device:

.

1. Dimension

DIMENSIONASTM D3578-05SGMP
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 sizes240 mm
Thickness - Finger0.08 mm min0.13 mm min
Palm0.08 mm min0.10 mm min
    1. Physical Properties (ASTM-D3578-05 Standard Specification for Latex Exam Gloves) on Lot# 7037 ి.
TENSILE STRENGTHULTIMATE ELONGATION
ASTM-D3578-05SGMPASTM-D3578-05SGMP
MpaMpa%%
Before Aging18.0650
X-Small23.5780
Small28.8920
Medium22.7835
Large25.5810
After Aging14.0500
X-Small21.8740
Small25.5850
Medium22.3780
Large23.8830

:

2

3. Water Tight Test

Batch #SizeSample SizeLeak StatusNumber Leaked
UN-AGED
7037X-Small125Yes2
7037Small125Yes2
7037Medium125Yes1
7037Large125Yes2
AGED
7037X-Small125No0
7037Small125Yes3
7037Medium125Yes2
7037Large125Yes1

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:

The above figures are within the ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.

Biocompatibility 4.

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

5. Total Residual Powder Content & Presence of Cornstarch

TestFDA RequirementInternal SGMP'S
Residual Powder Content
(ASTM D 6124-06)10 mg/ dm2 maxRange : 5.2 - 8.5 mg/ dm2
Mean : 7.5 mg / dm2

6. Residual Protein Level.

TestFDA Allowable levelClaimed Level
ASTM D 5712-99