(120 days)
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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.
Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.
The provided document is a 510(k) premarket notification for "Non-Sterile, Powder-Free, Latex Examination Gloves" and does not describe a study involving an algorithm or AI. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets them in the context of AI/algorithm performance.
However, I can extract the acceptance criteria and reported performance for the latex examination gloves as presented in the document, which primarily focuses on physical and chemical properties of the gloves.
Here's the information based on the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (ASTM D3578-01a & FDA 1000ml water test) | Reported Device Performance |
|---|---|---|
| Physical Properties (Before Aging) | ||
| Tensile Strength | 21. Mpa minimum | Meets criteria |
| Ultimate Elongation | 700% minimum | Meets criteria |
| Pinhole AQL | 1.5 minimum | Meets criteria |
| Physical Properties (After Aging) | ||
| Tensile Strength | 16.0 Mpa minimum | Meets criteria |
| Ultimate Elongation | 500% minimum | Meets criteria |
| Pinhole AQL | 1.5 minimum | Meets criteria |
| Dimensions | ||
| Overall Length | 240 mm minimum | Meets criteria |
| Width (medium glove) | 95 mm minimum | Meets criteria |
| Palm Thickness | 0.13 to 0.18 mm | Meets criteria |
| Finger Thickness | 0.15 to 0.20 mm | Meets criteria |
| Cuff Thickness | 0.10 to 0.15 mm | Meets criteria |
| Biocompatibility | Pass tests for examination gloves | Passed the tests |
| Residual Protein Level | < 50ugg | < 50ugg |
| Water Tight Test | AQL 1.5 | Meets criteria |
| Visual Major Defects | AQL 1.5 | Meets criteria |
| Visual Minor Defects | AQL 2.5 | Meets criteria |
| Powder Residue | Maximum 2mg/glove | Meets criteria |
Note: The document explicitly states: "These Powder-Free Latex Examination Gloves meet the physical property requirements of ASTM D 3578-01 and the FDA 1000 ml water test both before and after aging. It also meets the protein labeling claim level at < 50uggl". For specific physical dimensions and attributes, the table above lists the criteria, and the "Reported Device Performance" is inferred as "Meets criteria" based on the overall conclusion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document specifies "Inspection Parameters" with "Inspection Level" and "AQL" (Acceptable Quality Limit) values. These parameters imply a sampling plan for quality control tests, but do not directly state the specific sample size (n) for each test set. For example, "Inspection Level S-2" and "G-1" refer to sampling levels within ISO 2859-1:1999 (which is mentioned in the "Quality Assurance" section), which would then dictate the sample size based on the lot size.
- Sample size: Not explicitly stated as 'n=' for each test, but implied by inspection levels (S-2, G-1) and AQL values according to ISO 2859-1:1999.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is Ascend Eagle Inc. in American Canyon, CA, but the manufacturing location (and where the testing was performed) is not specified beyond "manufactured under ISO 9001:2000."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is a physical product (latex examination gloves) and not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for glove properties is established through standardized physical, chemical, and biological testing methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this pertained to a physical device evaluated against objective standards, not subjective expert assessment requiring adjudication.
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, as this is a physical device (examination gloves), not an AI or imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical device (examination gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the examination gloves is based on:
- Standardized physical measurements: Dimensions, tensile strength, elongation.
- Chemical analysis: Powder residue, extractable protein content.
- Performance tests: Water leak test (pinholes).
- Biocompatibility tests: Standardized tests for examination gloves (referenced in Appendix B1 and B2).
- Adherence to recognized standards: ASTM D 3578-01a, EN 455-1: 2000, EN 455-2: 2000, EN 455-3: 2000, ISO 2859-1:1999.
8. The sample size for the training set
Not applicable. The concept of a "training set" is relevant to machine learning/AI models, not to the manufacturing and testing of physical products like examination gloves. The manufacturing process would involve quality control measures, but not a "training set" in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device.
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JAN 2 5 2006
SUMMARY PREMARKET 510(k) NOTIFICATION
Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim.
510(k) Number (if known): K052666
Submission Applicant/Official Correspondent:
Jarilyn Lim, President Ascend Eagle Inc. 140-B, Dodd Court American Canyon, CA 94503 707-648-1526 Tel: Fax: 707-648-1534
Submitted: September 26, 2005
Description of the Device:
Trade and Proprietary Name: Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2. Predicative Devices: Latex Powder-Free Examination Gloves
Intended Use of the Device:
These patient examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
Substantial Equivalence:
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by US companies. It is Substantially Equivalent to the devices manufactured by SGMP Co., LTD, except by coating, K032293, and by N.S. Uni-Gloves Sdn. Bhd., except by scent, K013163.
Summary of Technological Characteristics:
Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-01a, EN 455-1: 2000, EN 455-2: 2000, EN 455-3: 2000, ISO 2859-1:1999 and manufactured under ISO 9001:2000.
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Inspection Parameters:
| Criteria | Inspection Level | AQL |
|---|---|---|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |
Physical Properties:
| Dimensions: | |
|---|---|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Palm Thickness: | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness: | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |
BEFORE AGING
Tensile Strength: 21. Mpa minimum Ultimate Elongation:700% minimum Pinhole AQL 1.5 minimum
AFTER AGING
16.0 Mpa minimum 500% minimum 1.5 minimum
Biocompatibility:
The biocompatibility test results are as per attached in Appendix B1 and B2 and show that the gloves passed the tests for examination gloves.
Residual Protein Level:
The extractable protein content test result is a per attached in Appendix B5 and show that the gloves meets the protein labeling claim level at < 50ugg.
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Conclusion: These Powder-Free Latex Examination Gloves meet the physical property requirements of ASTM D 3578-01 and the FDA 1000 ml water test both before and after aging. It also meets the protein labeling claim level at < 50uggl
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's wings. The eagle is positioned above a wavy line, likely representing water or a horizon. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2006
Ms. Jarilyn Lim President Ascend Eagle, Incorporated 140-B. Dodd Court American Canyon, California 94503
Re: K052666
Trade/Device Name: Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, with or Without Scent (Combined Citrus Peppermint), and with Protein Labeling Claim (50 Micrograms or Less of total water Soluble Protein Per Gram of Glove) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 3, 2006 Received: January 9, 2006
Dear Ms. Lim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Fxisting 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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Page 2 -- Ms. Lim
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 (OS) 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 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Carl
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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INDICATIONS FOR USE
APPLICANT:
Jarilyn Lim, President Ascend Eagle Inc. 140-B, Dodd Court American Canyon, CA 94503
510(k) NUMBER: K052666
DEVICE NAME:
Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, With or Without Scent (combined Citrus-Peppermint), and with Protein Labeling Claim (50 Micrograms or less of total water soluble protein per Gram of glove)
Indications For Use:
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F
and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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.
Prescription Use .............................. AND/ OR Per 21 CFR 801.109
Over-The -Counter Use ...... X ....... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula P. Murphy 12/25/06
U.S. Army General Hospital,
Medical Control, Dental Devices
§ 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.