(28 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 describes the acceptance criteria and the results of a study for "Non-Sterile Powder Free Vanilla Scented Latex Examination Gloves".
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria (ASTM-D3578-00 or FDA/SGMP requirements) and the device’s reported performance (SGMP's actual measurements or compliance statements).
| Criteria Category | Acceptance Criteria | Reported Device Performance (SGMP) |
|---|---|---|
| Dimensions (Width - X-Small) | 70 mm +/- 10 mm | 70 - 75 mm |
| Dimensions (Width - Small) | 80 mm +/- 10mm | 80 - 85 mm |
| Dimensions (Width - Medium) | 95 mm +/- 10mm | 90 - 97 mm |
| Dimensions (Width - Large) | 111mm +/- 10mm | 105 - 111 mm |
| Dimensions (Length - All) | 230 mm minimum | 252 mm |
| Dimensions (Thickness - Finger) | 0.08 mm min | 0.08 mm min |
| Dimensions (Thickness - Palm) | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | 14.0 Mpa (min) | X-S: 26.6, S: 27.5, M: 23.2, L: 25.7 Mpa (all > 14.0) |
| Ultimate Elongation (Before Aging) | 700 % (min) | X-S: 870, S: 870, M: 840, L: 860 % (all > 700) |
| Tensile Strength (After Aging) | 14.0 Mpa (min) | X-S: 21.8, S: 26.6, M: 23.7, L: 24.4 Mpa (all > 14.0) |
| Ultimate Elongation (After Aging) | 500 % (min) | X-S: 870, S: 950, M: 910, L: 910 % (all > 500) |
| Water Tight Test (AQL) | 2.5% AQL (FDA/ASTM D3578-00) | Un-aged: X-S (1/125), S (2/125), M (0/125), L (2/125) Aged: X-S (0/125), S (1/125), M (1/125), L (1/125). All within 2.5% AQL. |
| Biocompatibility | Passed tests for examination gloves (implicit) | Passed tests (per Appendix L) |
| Residual Powder Content | 2 mg/glove max (FDA Internal) | Mean: 1.2 mg/glove (Range: 0.8-1.6 mg/glove) |
| Presence of Cornstarch | Negative (FDA Internal) | Negative |
| Residual Protein Level | < 50 µg/g (ASTM D 5712-99) | < 50 µg/g |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Water Tight Test: 125 pieces for each of the four sizes (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested for watertightness (8 batches of 125).
- Sample Size for Physical Properties (Tensile Strength & Elongation): Specific sample sizes for each measurement are not explicitly stated, but the results are reported for "Lot# 1123" across all sizes.
- Data Provenance: The document does not specify the country of origin of the data beyond "SGMP" (the applicant company) and adherence to ASTM/FDA standards. The data appears to be prospective as it involves specific tests conducted on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical product (latex examination gloves), and the "ground truth" for its performance is established through adherence to recognized physical, chemical, and biological standards (ASTM, FDA) rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements and adherence to pass/fail criteria defined by standards, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical product, not a medical imaging device or diagnostic algorithm that would involve human readers.
6. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study
Not applicable. This is a physical product, not an algorithm.
7. Type of Ground Truth Used
The ground truth for this device is based on generally accepted industry standards and regulatory requirements. Specifically:
- Physical Properties: ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
- Water Tight Test: FDA specified 1,000 ml water leak test and FDA/ASTM D3578-00 requirements (2.5% AQL).
- Biocompatibility: Tests for examination gloves (results attached in Appendix L, not provided in the excerpt).
- Residual Powder Content: FDA internal SGMP's requirement (2 mg/glove max).
- Presence of Cornstarch: FDA internal SGMP's requirement (negative).
- Residual Protein Level: ASTM D 5712-99 (< 50 µg/g).
8. Sample Size for the Training Set
Not applicable. This is a manufactured product, not an AI/ML algorithm requiring a "training set." The manufacturing process is validated (e.g., against ISO or GMP standards, though not explicitly detailed here beyond the tests performed on production lots).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML algorithm. The "ground truth" for manufacturing involves continuous quality control and adherence to documented specifications and standards throughout production.
{0}------------------------------------------------
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-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 | 252 mm |
| Thickness -FingerPalm | 0.08mm min0.08mm min | 0.08 mm min0.08 mm min |
1. Dimension
{1}------------------------------------------------
| 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 | NUMBERLEAKED |
|---|---|---|---|---|
| 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.
{2}------------------------------------------------
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 | < 50 µg/g | < 50 µg/g |
Conclusion:-
The data presented indicate that the Non-sterile Powder Free Vanilla Scented latex examination glove
meets/exceeds ASTM- D3578-00 Standard Specifications For Latex Examination Glove, .
ﺳﯿﻨ
-
- meets FDA pinhole requirements,
- meets FDA claim criterion of a powder free glove. র প
-
- meets the protein labeling claim level at <50 ug/g.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2001
SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434
Re: K012863
Trade/Device Name: Non-Sterile Powder Free Latex Examination Gloves with Vanilla And Protein Content Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 23, 2001 Received: August 24, 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
{4}------------------------------------------------
Page 2 - Ms. Tucker
mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at 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
Enclosure
{5}------------------------------------------------
INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER : K. Ol 286 3
Device,Name : Non-sterile Powder Free Latex Examination Gloves with Vanilla Seent
AND PROTEIN CONTENT LABELING CLAIM | ED MICROGRAMS OC LE55' 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
Qia S. lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.