(14 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 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
This looks like a 510(k) premarket notification for examination gloves, which are low-risk devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the device meets established ASTM standards and FDA requirements for such products, rather than clinical efficacy trials common for higher-risk medical devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D6319-00aE3 / FDA) | Reported Device Performance (POLYMER COATED POWDER FREE NITRILE EXAM GLOVES) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | 240 mm minimum for all sizes |
| M | Min 230 | 240 mm minimum for all sizes |
| L | Min 230 | 240 mm minimum for all sizes |
| XL | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) | ||
| Size XS | - | <80 mm |
| S | 80 +/- 10 | 85 +/- 3 mm |
| M | 95 +/- 10 | 95 +/- 3 mm |
| L | 111 +/- 10 | 105 +/- 3 mm |
| XL | - | 111 +/- 3 mm |
| XXL | - | 120 +/- 3 mm |
| Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | 0.08 minimum |
| Palm | Min 0.05 | 0.08 minimum |
| Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 20.4* |
| Ultimate Elongation (%) | Min 500 | 618* |
| Physical Properties - After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 21.3* |
| Ultimate Elongation (%) | Min 400 | 616* |
| Powder Content | - (FDA Requirements implicit) | Below 2mg / glove |
| Biocompatibility | (Implicitly, to pass standards) | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test |
Note: The asterisk indicates "the average results from Attachment C," which is not provided in the input text but is referenced for the physical properties data.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "AQL=2.5%" for the watertight test, which refers to an Acceptance Quality Limit often used in sampling plans for quality control, but it does not specify the exact number of gloves or batches tested. Similarly, for other tests like length, width, and thickness, it provides minimums or averages but not the number of samples from which these were derived. For physical properties, it mentions "average results from Attachment C" without specifying the sample size.
- Data Provenance: The study was conducted by SPI GLOVES SDN. BHD. in Malaysia. The type is assumed to be prospective manufacturing quality control testing as part of the market approval process, rather than a retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for examination gloves is established by objective measurements against quantitative physical and chemical standards (like ASTM D6319-00aE3 and FDA requirements) rather than expert opinion or interpretation.
4. Adjudication method for the test set
Not applicable. As the "ground truth" relies on objective measurements against established standards, there is no need for expert adjudication. Tests either pass or fail the specified criteria.
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. MRMC studies are used for diagnostic imaging or similar applications where human readers interpret complex data, often with AI assistance. This submission is for a physical medical device (examination gloves) and does not involve AI or human interpretation of medical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D6319-00aE3 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- FDA 1000 ml watertight test requirements
- FDA minimum powder residual content requirements
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)
8. The sample size for the training set
Not applicable. This is a submission for a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
{0}------------------------------------------------
MAR 1 6 2305 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 23, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Polymer Coated Powder Free Nitrile ExaminationGloves (Blue, White, Violet, Pink, Green) | |
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
Identification of the Legally Marketed Devices 4.0
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 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 Q
{1}------------------------------------------------
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
Summary of Performance Data: 7.
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| POLYMER COATED POWDERFREE NITRILE EXAM GLOVES | |||
|---|---|---|---|
| TEST | ASTM D6319-00aE3 | Pass GI | AQL=2.5% |
| 1. Watertight (1000 ml) | GIAQL=2.5% | ||
| 2. Length (mm) | |||
| Size XS | Min 230 | 240 mm minimum forall sizes | |
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | Min 230 | ||
| 3. Palm width (mm) | |||
| Size XS | - | <80 mm | |
| S | 80 +/- 10 | 85 +/- 3 mm | |
| M | 95 +/- 10 | 95 +/- 3 mm | |
| L | 111 +/- 10 | 105 +/- 3 mm | |
| XL | - | 111 +/- 3 mm | |
| XXL | - | 120 +/- 3 mm | |
| 4. Thickness (mm)(Single Layer) | |||
| Finger | Min 0.05 | 0.08 minimum | |
| Palm | Min 0.05 | 0.08 minimum | |
| 5. Physical Properties | |||
| Before Aging | |||
| Tensile Strength (Mpa) | Min 14.0 | 20.4* | |
| Ultimate Elongation (%) | Min 500 | 618* | |
| After Aging | |||
| Tensile Strength (Mpa) | Min 14.0 | 21.3* | |
| Ultimate Elongation (%) | Min 400 | 616* | |
| 6. Powder Content | - | Below 2mg / glove |
- indicates the average results from Attachment C. .
{2}------------------------------------------------
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 D6319-00a53 છે. Standard and FDA's requirement. Standard and I'DA'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 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- Conclusion 10.
We concluded that the Polymer Coated Powder Free Nitrile Examination Gloves mect the below specifications:
- ASTM D6319-00a53 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content --
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
MAR 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA
Re: K050530
KU5030
Trade/Device Name: Polymer Coated Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2005 Reccived: March 2, 2005
Dear Ms. Chooi Fong:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaled by the device is substantially equivalent (for the referenced above and have determined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate continetee proof to that have been reclassified in accordance with the provisions of Allientificals, of to devices that tic Act (Act) that do not require approval of a premarket the reachar I vou, Drag, und Connects , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ricaration, 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 If your device is classified (500 above) in the subject to thisting major regulations afficeing (PMA), It may be subject to Sach adaxi Regulations. Title 21. Parts 800 to 898. In your device can be found in firsther announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 -- Ms. Chooi Fong
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's Issuance of a stustinates with other requirements
mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a delemination that your and your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registra of the Act or any bederal statues and reginations and hot limited to: registration
You must comply with all the Act step of and annufacturing practice You must comply with all the Act 3 requirements, interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820); and i and listing (2) CFR Part 807); labeling (21 CFR Parts); Beach (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Parl 820); an requirements as set forth in the quality Systems (QS) regalation (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the success of the same and starticle spiralence of your device t This letter will anow you to begin matically your and equivalence of your device to a
premarket notification. The FDA finding of substantial from your dowee and thus, per premarket notification. The FDA miding of substantial equively of 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 Patt 801), If you desire specific advice for your device of (240) 276-0115. Also, please note the regulation prease contact the Office or Comphanes and premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain offer general mironmation on your and Consumer Assistance at its toll-free Division of Small or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
{5}------------------------------------------------
INDICATIONS FOR USE
: SPI Gloves Sdn. Bhd. Applicant
510(K) Number : K 050530
: Polymer Coated Powder Free Nitrile Examination Gloves (Blue, Device Name White, Violet, Pink, Green)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hands or finger to prevent contamination between patient and examiner.
Prescription Use: ....................................... (Part 21 CFR 801 Subpart D)
Over-The-Counter ....................... AND/OR (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)
Shule A. Murphy, MD
General Hospital
Dental Devices
A-05030
Page 5
§ 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.