(279 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" and FDA Water Leak Test.
The provided document describes the acceptance criteria and performance data for "Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves."
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D3578-01aE2 & FDA) | Reported Device Performance (POLYMER COATED ONLINE CHLORINATED POWDER FREE LATEX EXAM GLOVES) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) (all sizes) | Min 230 | 240 mm minimum |
| 3. Palm width (mm) | ||
| Size XS | - | <80 mm |
| Size S | 80 +/- 10 | 85 +/- 3 mm |
| Size M | 95 +/- 10 | 95 +/- 3 mm |
| Size L | 111 +/- 10 | 105 +/- 3 mm |
| Size XL | - | >110 mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties | ||
| Before Aging: | ||
| Tensile Strength (Mpa) | Min 14.0 | 23.9 |
| Ultimate Elongation (%) | Min 650 | 812 |
| After Aging: | ||
| Tensile Strength (Mpa) | Min 14.0 | 19.3 |
| Ultimate Elongation (%) | Min 500 | 741 |
| 6. Powder Content | Below 2mg / glove (FDA requirement) | Below 2mg / glove |
| 7. Protein Content | Below 50 microgram / gram | Below 50 microgram / gram |
| 8. Biocompatibility Tests | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test | Pass Biocompatibility Tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. However, it indicates compliance with ASTM D3578-01aE2 standards and FDA requirements. The data provenance is linked to SPI Gloves Sdn. Bhd. in Malaysia, and the tests were likely conducted by or for this manufacturer. The nature of the tests (physical properties, watertightness, etc.) suggests these are controlled laboratory tests rather than observational studies in a real-world setting. The summary was prepared on February 11, 2005.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the performance of examination gloves is established by objective, standardized tests and measurements as defined by ASTM D3578-01aE2 and FDA requirements, not by expert consensus or interpretation of subjective data. Physical properties, chemical content, and watertightness are quantifiable metrics.
4. Adjudication method for the test set
Not applicable. As described above, the performance is measured against objective standards, not subjective interpretation 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. This device is a medical glove, not an AI-assisted diagnostic tool or an imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not a software algorithm.
7. The type of ground truth used
The ground truth used for evaluating the device is based on objective, quantitative standards and tests specified by:
- ASTM D3578-01aE2 (Standard Specification for Rubber Examination Gloves)
- FDA 1000 ml watertight test
- FDA minimum powder residual content requirements
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)
- Protein content testing (below 50 microgram / gram)
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
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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DEC 6 2005
SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SPI GLOVES SDN. BHD.5, Persiaran Greentown 8,Greentown Business Centre,30450 Ipoh, Perak, Malaysia. |
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | February 11, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Polymer Coated Online Chlorinated Powder FreeLatex Examination Gloves | |
| Common Name | Exam Glove | |
| Classification Name | Latex Patient Examination Glove |
Identification of the Legally Marketed Devices 4.0
Class 1 Latex Pationt Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" and FDA Water Leak Test.
6.0 The Intended Use of Glove
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Page 1 of 3 ATTACHMENT O
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SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
7. Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01a" and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2 | POLYMER COATED ONLINE CHLORINATED POWDER FREE LATEX EXAM GLOVES | ||
|---|---|---|---|---|
| 1. Watertight (1000 ml) | GI | AQL=2.5% | Pass GI | AQL=2.5% |
| 2. Length (mm)Size XSSMLXL | Min 230Min 230Min 230Min 230Min 230 | 240 mm minimum forall sizes | ||
| 3. Palm width (mm)Size XSSMLXL | -80 +/- 1095 +/- 10111 +/- 10- | <80 mm85 +/- 3 mm95 +/- 3 mm105 +/- 3 mm>110 mm | ||
| 4. Thickness (mm)(Single Layer)FingerPalm | Min 0.08Min 0.08 | 0.10 minimum0.10 minimum | ||
| 5. Physical PropertiesBefore AgingTensile Strength (Mpa)Ultimate Elongation (%) | Min 14.0Min 650 | *23.9*812 | ||
| After AgingTensile Strength (Mpa)Ultimate Elongation (%) | Min 14.0Min 500 | *19.3*741 | ||
| 6. Powder Content | - | Below 2mg / glove | ||
| 7. Protein Content | - | Below 50 microgram / gram |
- The average result obtained from Attachment C.
Page 2 of 3 ATTACHMENT O
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SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
- The performance data of the glove as showed above meet the ASTM D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
-
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves meet the below specifications:
- ASTM D3578-01a'-- Standard -
- -FDA pinhole requirements
- -FDA minimum powder residual content
Page 3 of 3 ATTACHMENT O
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
DEC & 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management Systems Manager SPI Gloves Sdn. Bhd 5, Persiaran Greentown 8, Greentown Business Center, 30450 Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K050526
Trade/Device Name: Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 24, 2005 Received: November 28, 2005
Dear Ms. Fong:
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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Page 2 - Ms. Fong
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 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.
Sincercly yours,
Snette y. Michael Ons.
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
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INDICATIONS FOR USE STATEMENT
Applicant : SPI Gloves Sdn. Bhd.
510(K) Number :
- Device Name : Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 micrograms or less of Total Water Extractable Protein per Gram)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODC)
Prescription Use: .......... Per 21 CFR 80.109
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Over-The-Counter ..... X ..........
Shida A. Humphrey, MD 12/6/05
A050526
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§ 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.