(15 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the POWDER FREE GREEN COLOR SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES:
1. Table of Acceptance Criteria and Reported Device Performance:
The device (SGMP's) is compared against the ASTM D6319-00a standard (except for elongation at break, for which SGMP's performance is listed directly).
| Acceptance Criteria Category | Specific Parameter | ASTM D6319-00a (Acceptance Criteria) | SGMP's Reported Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Dimension | X-Small Width | 70 mm +/- 10 mm | 70 - 75 mm | Yes |
| Small Width | 80 mm +/- 10mm | 80 - 85 mm | Yes | |
| Medium Width | 95 mm +/- 10mm | 90 - 97 mm | Yes | |
| Large Width | 111mm +/- 10mm | 105 - 111 mm | Yes | |
| Length (all sizes) | 230 mm minimum | 242mm | Yes | |
| Thickness - Finger | 0.08mm min | 0.08 mm min | Yes | |
| Thickness - Palm | 0.08mm min | 0.08 mm min | Yes | |
| Physical Properties | Tensile Strength (Before Aging) | 14.0 MPa | X-Small: 16.5 MPaSmall: 16.0 MPaMedium: 15.3 MPaLarge: 17.6 MPa | Yes (Exceeds) |
| Tensile Strength (After Aging) | 14.0 MPa | X-Small: 17.1 MPaSmall: 18.0 MPaMedium: 17.5 MPaLarge: 19.4 MPa | Yes (Exceeds) | |
| Ultimate Elongation (Before Aging) | 500 % | X-Small: 650 %Small: 680 %Medium: 700 %Large: 670 % | Yes (Exceeds) | |
| Ultimate Elongation (After Aging) | 400 % | X-Small: 680 %Small: 670 %Medium: 690 %Large: 720 % | Yes (Exceeds) | |
| Water Tight Test | AQL for Leaks | 2.5% AQL (ASTM D3578-00) | UN-AGED: 1/125 (X-Small), 0/125 (Small), 2/125 (Medium), 1/125 (Large) AGED: 0/125 (X-Small), 1/125 (Small), 1/125 (Medium), 0/125 (Large) | Yes (All reported within 2.5% AQL) |
| Biocompatibility | Dermal Irritation | Not a dermal irritant | Not a dermal irritant | Yes |
| Skin Sensitization | Not a skin sensitizer | Not a skin sensitizer | Yes | |
| Residual Powder Content | Residual Powder Content | 2 mg/glove max | Range: 0.7-1.5mg/gloveMean: 1.05 mg/glove | Yes |
| Presence of Cornstarch | Negative | Negative | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Dimension, Tensile Strength, Ultimate Elongation, Residual Powder, Cornstarch: Not explicitly stated for each test, but the results are reported for "SGMP's" and indicate measurements across different sizes (X-Small, Small, Medium, Large) and under "Before Aging" and "After Aging" conditions. The specific number of gloves tested for each individual measurement (e.g., how many gloves were measured for X-Small tensile strength before aging) is not provided.
- Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested for both un-aged and aged conditions. This totals 1000 gloves (4 sizes * 125 gloves/size * 2 aging conditions).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing conducted by "SGMP's" (the manufacturer) for submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a physical product (examination gloves), not an AI/imaging device that requires expert interpretation for ground truth. Therefore, the concepts of "experts" and their "qualifications" as typically applied to medical image analysis or diagnostic AI studies are not relevant here. The ground truth for these tests is established by physical measurement against established laboratory standards (e.g., ASTM D6319-00a, ASTM D3578-00, ASTM D6124-00, biocompatibility testing protocols).
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of expert opinions or interpretations. The tests are based on objective physical and chemical properties measured against defined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted device, nor does it involve human "readers" or case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used:
The ground truth used is based on established industry standards and laboratory testing protocols. Specifically:
- ASTM-D6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application for dimensions, tensile strength, and ultimate elongation.
- FDA specified 1,000 ml water leak test, evaluated against ASTM D3578-00 requirements for examination gloves (2.5% AQL).
- Biocompatibility tests (dermal irritation and skin sensitizer testing).
- ASTM D 6124-00 for Residual Powder Content.
- Tests for the Presence of Cornstarch.
8. The sample size for the training set:
Not applicable. There is no training set as this is a physical product, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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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:
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.
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 minimumfor all sizes | 242mm |
| Thickness - Finger | 0.08mm min | 0.08 mm min |
| Thickness - Palm | 0.08mm min | 0.08 mm min |
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| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTMD 6319-00a | SGMP's | ASTMD 6319-00a | SGMP's | |
| Before AgingX-SmallSmallMediumLarge | 14.0MPa | 16.516.015.317.6MPa | 500% | 650680700670% |
| After AgingX-SmallSmallMediumLarge | 14.0 | 17.118.017.519.4 | 400 | 680670690720 |
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 | NUMBERLEAKED |
|---|---|---|---|---|
| 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.
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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
| TESTSREQUIREMENT | FDA | SGMP's |
|---|---|---|
| Residual PowderContent(ASTM D 6124-00) | 2 mg/glove max | Range: 0.7-1.5mg/gloveMean : 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,
-
- meets FDA pinhole requirements,
-
- meets FDA claim criterion of a powder free glove,
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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
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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
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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
OR
Over-The-Counter ... ... ... ... ...
Olin S. Lium
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __
2
§ 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.