(62 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 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.
The provided document is a 510(k) summary for "NON-STERILE POWDER FREE GREEN LATEX EXAM GLOVES WITH ALOE VERA & VITAMINE" and does not describe an AI medical device. The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically relevant for AI/ML-based diagnostic or prognostic devices, not for a medical glove.
Therefore, I cannot provide the information requested in the format of the prompt, as it is not applicable to the given document.
The document describes the performance characteristics of medical gloves against ASTM standards and FDA requirements. These are not "AI device performance metrics" in the sense of the prompt.
However, I can extract the closest analogous information from the document as it relates to the glove's performance against established criteria:
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (ASTM D3578-00 or FDA) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimensions (Width) | ||
| X-Small | 70 mm +/- 10 mm | 70 - 75 mm |
| Small | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium | 95 mm +/- 10 mm | 90 - 97 mm |
| Large | 111 mm +/- 10 mm | 105 - 111 mm |
| Dimensions (Length) | 230 mm minimum | 252 mm |
| Thickness | ||
| Finger | 0.08 mm min | 0.08 mm min |
| Palm | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | ||
| X-Small | 14.0 Mpa | 25.8 Mpa |
| Small | 14.0 Mpa | 27.8 Mpa |
| Medium | 14.0 Mpa | 27.9 Mpa |
| Large | 14.0 Mpa | 27.1 Mpa |
| Tensile Strength (After Aging) | ||
| X-Small | 14.0 Mpa | 24.1 Mpa |
| Small | 14.0 Mpa | 27.0 Mpa |
| Medium | 14.0 Mpa | 28.7 Mpa |
| Large | 14.0 Mpa | 25.6 Mpa |
| Ultimate Elongation (Before Aging) | ||
| X-Small | 700 % | 830 % |
| Small | 700 % | 920 % |
| Medium | 700 % | 900 % |
| Large | 700 % | 950 % |
| Ultimate Elongation (After Aging) | ||
| X-Small | 500 % | 950 % |
| Small | 500 % | 910 % |
| Medium | 500 % | 910 % |
| Large | 500 % | 910 % |
| Water Leak Test | 2.5% AQL (Acceptance Quality Limit) | Leaked: X-Small (1), Small (0), Medium (1), Large (2) for UN-AGED. X-Small (0), Small (1), Medium (2), Large (0) for AGED. All within 2.5% AQL. |
| Biocompatibility | Passed tests for examination gloves | Passed |
| Residual Powder Content | 2 mg/glove max (FDA Internal Requirement) | Range: 0.5-0.8 mg/glove; Mean: 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level | < 50 µg/g (FDA Allowable Level) | < 50 µg/g |
The remaining points (2-9) are specific to AI device studies and are not applicable to this 510(k) submission for latex examination gloves, which focuses on physical and chemical properties and safety for an inert medical device.
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APPENDIX M
DEC 3 - 2001
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA & VITAMIN E
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 GREEN LATEX EXAM GLOVES WITH ALOE VERA & VITAMINE WITH PRODUCTION LABELING CLAIM (450 Micros
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-SmallSmallMediumLarge | 70 mm +/- 10 mm80 mm +/- 10mm95 mm +/- 10mm111mm +/- 10mm | 70 - 75 mm80 - 85 mm90 - 97 mm105 - 111 mm |
| Length | 230 mm minimumfor all sizes | 252mm |
| Thickness -FingerPalm | 0.08mm min0.08mm min | 0.08 mm min0.08 mm min |
1. Dimension
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| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP | |
| Before AgingX-SmallSmallMediumLarge | Mpa14.0 | Mpa25.827.827.927.1 | %700 | %830920900950 |
| After AgingX-SmallSmallMediumLarge | 14.0 | 24.127.028.725.6 | 500 | 950910910910 |
2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1186
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 #1186 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| UN-AGED | X-Small | 125 | Yes | 1 |
| Small | 125 | No | 0 | |
| Medium | 125 | Yes | 1 | |
| Large | 125 | Yes | 2 | |
| AGED | X-Small | 125 | No | 0 |
| Small | 125 | Yes | 1 | |
| Medium | 125 | Yes | 2 | |
| Large | 125 | No | 0 |
The above figures are within the gloves of 2.5% AQL.
FDA/ASTM D3578-00 requirements for latex exam
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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.
5. Total Residual Powder Content & Presence of Cornstarch
| TESTS | FDA INTERNALREQUIREMENT | SGMP's |
|---|---|---|
| Residual PowderContent(ASTM D 6124-00) | 2 mg/glove max | Range: 0.5-0.8mg/gloveMean : 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | < 50 µg/g | < 50 µg/g |
Conclusion:- -
The data presented indicate that the Non-sterile Powder Free Green latex examination glove with Aloe Vera & Vitamin E
-
- meets/exceeds ASTM- D3578-00 Standard Specifications For Latex Examination Glove,
-
- meets FDA pinhole requirements,
-
- meets FDA claim criterion of a powder free glove.
-
- meets the protein labeling claim level at <50 µg/g.
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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CEC 3 - 2001
SGMP Company, Limited C/O Ms. Janna Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434
Re: K013288
Trade/Device Name: Non-Sterile Powder Free Green Latex Examination Gloves with Vitamin E and Aloe Vera, Protein Labeling Claim ( 50 micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: September 28, 2001 Received: October 2, 2001
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualles or a basevice complies with other requirements mean that ITDA has made a decemmations administered by other Federal agencies. of the Act of ally I edelar statues and regareers, including, but not limited to: registration You must comply with an the Piece requires (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat 820), and if requirents as set form in the quality by overly browns (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 organ marketing of substantial equivalence of your device to 510(K) premarket notheation: "110 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 ad not 10. Jour 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) 594-4639 contact the Office of Compliance at (301) 594-4639. advertising or your and the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (21 OF ICP and of Small Manufacturers, International and the Act may be obtained its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER :
Device Name : Non-sterile Powder Free Green Latex Examination Gloves with Aloe Vera and Vitamin E , Profess Labeling
Indication 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 ................
2
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Dev 510(k) Number _
§ 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.