(395 days)
A 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.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device: "Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (<50uG/G)".
The document describes the device's acceptance criteria and how its performance was demonstrated.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (ASTM-D3578-01aE2 or FDA Internal) | Reported Device Performance (SGMP LOT# 2206) |
|---|---|---|
| Dimension | ||
| X-Small (Width) | 70 mm +/- 10 mm | 70 - 75 mm |
| Small (Width) | 80 mm +/- 10mm | 80 - 85 mm |
| Medium (Width) | 95 mm +/- 10mm | 95 - 97 mm |
| Large (Width) | 111mm +/- 10mm | 105 - 111 mm |
| Length (all sizes) | 230 mm minimum | 242 mm |
| Finger Thickness | 0.08 mm min | 0.08 mm min |
| Palm Thickness | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Mpa) | ||
| Before Aging | 14.0 | 22.0 (X-Small), 22.8 (Small), 24.7 (Medium), 23.5 (Large) |
| After Aging | 14.0 | 25.4 (X-Small), 25.2 (Small), 25.6 (Medium), 24.3 (Large) |
| Ultimate Elongation (%) | ||
| Before Aging | 700 | 770 (X-Small), 790 (Small), 830 (Medium), 820 (Large) |
| After Aging | 500 | 860 (X-Small), 810 (Small), 860 (Medium), 840 (Large) |
| Water Tight Test (AQL) | 2.5% AQL (FDA/ASTM D3578-01aE2) | Within 2.5% AQL (see detailed results below) |
| 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 | <50 µg/g (implied by "Conclusion" statement) |
| Biocompatibility | Passed relevant tests | Passed (as per Appendix M) |
Detailed Water Tight Test Results (LOT# 2206):
| Condition | Size | Sample Size | Number Leaked |
|---|---|---|---|
| UN-AGED | X-Small | 125 | 1 |
| UN-AGED | Small | 125 | 0 |
| UN-AGED | Medium | 125 | 1 |
| UN-AGED | Large | 125 | 2 |
| AGED | X-Small | 125 | 0 |
| AGED | Small | 125 | 1 |
| AGED | Medium | 125 | 2 |
| AGED | Large | 125 | 1 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged conditions, totaling 1000 gloves.
- For Physical Properties (Tensile Strength, Ultimate Elongation): Lot# 2206 was tested, but specific sample sizes for each measurement are not explicitly stated beyond lot number. However, ASTM D3578-01aE2 typically defines sampling plans.
- For Residual Powder Content: Not specified beyond a "Range" and "Mean."
- For Biocompatibility: "the gloves passed the tests in question records" in Appendix M suggests testing was performed according to guidelines, but sample size is not stated.
- Data Provenance: The document does not specify the country of origin of the data. It implies retrospective testing on manufactured gloves (Lot# 2206).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for the performance of these gloves is established through standardized physical, chemical, and biological tests based on established specifications like ASTM-D3578-01aE2 and FDA requirements, rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable. As stated above, performance is measured against objective standards, not through adjudication of expert interpretations.
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:
This information is not applicable. This is a physical, non-AI medical device (patient examination gloves), and therefore, no MRMC study involving human readers or AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical device, not an algorithm, so no standalone algorithm performance study was done.
7. The Type of Ground Truth Used:
The ground truth used is based on:
- Standard Specifications: ASTM-D3578-01aE2 "Standard Specification for Latex Examination Gloves for Medical Application."
- FDA Internal Requirements: For water tight tests, residual powder content, and specified protein labeling claim (<50 µg/g).
- Biocompatibility Standards: Implied by "passed the tests in question" as per Appendix M.
8. The Sample Size for the Training Set:
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with the head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2003
SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K023537
Trade/Device Name: Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (<50uG/G) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 16, 2003 Received: September 17, 2003
Dear Ms. Tucker:
This letter corrects our substantially equivalent letter of November 20, 2003 regarding the address.
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 (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 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 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 (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 continue marketing your device as described in your Section 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 Part 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
QurLs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX N
510(k) SUMMARY FOR:
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAMINATION GLOVES WITH NOPAL/ALOE VERA/VITAMIN E AND DONNING AID COATING, AND WITH PROTE LABELING CLAIM (<50ug/them)
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 PATIENT EXAMINATION GLOVES WITH NOPAL/ALOE VERA/VITAMIN E
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-D3578-01a22 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-D3578-01ar2 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:
1. Dimension
| DIMENSION | ASTM D3578-01ae2 | SGMP | |
|---|---|---|---|
| X-Small | 70 mm +/- 10 mm | 70 - 75 mm | |
| Small | 80 mm +/- 10mm | 80 - 85 mm | |
| Medium | 95 mm +/- 10mm | 95 - 97 mm | |
| Large | 111mm +/- 10mm | 105 - 111 mm | |
| Length | 230 mm minimumfor all sizes | 242mm | |
| Thickness - | Finger | 0.08mm min | 0.08 mm min |
| Palm | 0.08mm min | 0.08 mm min |
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| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-01aE2 SGMP | SGMP | ASTM-D3578-01aE2 SGMP | SGMP | |
| Before Aging | Mpa14.0 | Mpa | %700 | % |
| X-SmallSmallMediumLarge | 22.022.824.723.5 | 770790830820 | ||
| After AgingX-SmallSmallMediumLarge | 14.0 | 25.425.225.624.3 | 500 | 860810860840 |
2. Physical Properties (ASTM-D3578-01aE2 Standard Specification for Latex Exam Gloves) on Lot# 2206
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 1.25 pieces of each size of the gloves were tested and our results are as given below:
| LOT # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| UN-AGED | ||||
| 2206 | X-Small | 125 | Yes | 1 |
| 2206 | Small | 125 | No | 0 |
| 2206 | Medium | 125 | Yes | 1 |
| 2206 | Large | 125 | Yes | 2 |
| AGED | ||||
| 2206 | X-Small | 125 | No | 0 |
| 2206 | Small | 125 | Yes | 1 |
| 2206 | Medium | 125 | Yes | 2 |
| 2206 | Large | 125 | Yes | 1 |
FDA/ASTM D3578-01aE2 requirements for latex exam The above figures are within the gloves of 2.5% AQL.
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Biocompatibility 4.
The bio-compatibility test results are as per Appendix M which shows that the gloves passed the tests in question.
5. Total Residual Powder Content & Presence of Cornstarch
| TESTS | FDA INTERNALREQUIREMENT | SGMP's |
|---|---|---|
| Residual PowderContent(ASTM D 6124-01) | 2 mg/glove max | Range: 0.5-0.8mg/gloveMean : 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
6. Residual Protein Level
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Conclusion:-
The data presented indicate that the Powder Free latex examination glove
- meets/exceeds ASTM- D3578-01az2 Standard Specification for Latex Examination Gloves ..............................................................................................................................................................................
- . . 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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INDICATIONS FOR USE
| APPLICANT: | SGMP COMPANY LIMITED |
|---|---|
| 510(k) NUMBER: | K023537 |
| DEVICE NAME: | NON-STERILE POWDER FREEGREEN LATEX PATIENTEXAMINATION GLOVES WITHNOPAL/ALOE VERA/VITAMIN EAND DONNING AID COATING, ANDWITH PROTEIN LABELING CLAIM(< 50uG/G) |
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susanne F. Barre D | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K023537 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 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.