(16 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, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D3578-01aE2 or FDA requirement) | Reported Device Performance (POWDERED NITRILE EXAM GLOVES AQL=2.5%) |
|---|---|---|
| 1. Watertight (1000 ml) | G I (AQL=2.5%) | Pass GI (AQL=2.5%) |
| 2. Length (mm) - various sizes | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) - XS | - | <80 mm |
| 3. Palm width (mm) - S | 80 +/- 10 | 85 +/- 3 mm |
| 3. Palm width (mm) - M | 95 +/- 10 | 95 +/- 3 mm |
| 3. Palm width (mm) - L | 111 +/- 10 | 105 +/- 3 mm |
| 3. Palm width (mm) - XL | - | 111 +/- 3 mm |
| 3. Palm width (mm) - XXL | - | 120 +/- 3 mm |
| 4. Thickness (mm) (Single Layer) - Finger | Min 0.08 | 0.08 minimum |
| 4. Thickness (mm) (Single Layer) - Palm | Min 0.08 | 0.08 minimum |
| 5. Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 30.4 |
| Ultimate Elongation (%) | Min 650 | 640 |
| 5. Physical Properties - After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 30.9 |
| Ultimate Elongation (%) | Min 500 | 610 |
| 6. Powder Content | - (FDA Requirement) | Below 10 mg / dm2 |
| Biocompatibility Test (Primary Dermal Irritation) | Pass | Pass |
| Biocompatibility Test (Guinea Pig Sensitization) | Pass | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the specific sample sizes used for each test. However, it indicates an AQL=2.5% for the watertight test, which implies a sampling plan based on statistical quality control standards like ISO 2859-1 (which ASTM D3578 references). For other tests (length, width, thickness, physical properties), a specific sample size is not provided.
- Data Provenance: The testing was performed by SPI GLOVES SDN. BHD., a company located in Ipoh, Perak, Malaysia. The data is likely prospective as it represents the performance data for the specific device manufactured by the submitter.
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 section is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM D6319-00a53, FDA requirements) and laboratory tests, not through expert interpretation or clinical ground truth in the way medical imaging or diagnostic algorithms are. The "ground truth" is defined by these objective standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As explained above, the evaluation relies on objective measurements and compliance with technical standards and lab tests, 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
This section is not applicable. This describes a physical product, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This describes a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective technical standards and laboratory testing. Specifically:
- ASTM D6319-00a53 Standard
- FDA 1000 ml watertight test
- FDA minimum powder residual content
- Biocompatibility Tests (Primary Dermal Irritation Test and Guinea Pig Sensitization)
8. The sample size for the training set
This section is not applicable. This device is a manufactured product, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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MAR 1 8 2005
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymcr.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 25, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Powdered Nitrile Examination Glove | |
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
Description of The Device 5.0
Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which 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.
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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
Summary of Performance Data: 7.
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2AQL=2.5% | POWDERED NITRILE EXAMGLOVESAQL=2.5% |
|---|---|---|
| 1. Watertight (1000 ml) | G I | Pass GI |
| 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 0.08 | 0.08 minimum |
| Palm | Min 0.08 | 0.08 minimum |
| 5. Physical PropertiesBefore Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 30.4 |
| Ultimate Elongation (%) | Min 650 | 640 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 30.9 |
| Ultimate Elongation (%) | Min 500 | 610 |
| 6. Powder Content | - | Below 10 mg / dm2 |
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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 D6319-00a53 8. Standard and FDA's requirement. Powder content is below 10 mg per dm2, which meet the FDA Requirements.
- ਹੇ. 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 Powdered Nitrile Examination Gloves meet the below specifications:
- ASTM D6319-00a53 Standard -
- FDA pinhole requirements -
- -FDA minimum powder residual content
Page 3 of 3 ATTACHMENT N
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Ouality Management System Manager SPI Gloves SND. BHD. 5. Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA
Re: K050531
Trade/Device Name: Powdered Nitrile Examination Gloves (Blue, White) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2005 Received: March 2, 2005
Dear. Ms. Chooi 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. Chooi 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 mav 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.
Sophie Michie and
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
: SPI Gloves Sdn. Bhd. Applicant
510(K) Number : K050531
Device Name : Powdered Nitrile Examination Gloves (Blue, White)
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.
Prescription Use: ................................... (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter ....................... (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)
Shade H. Murphy, R 2/1/05
nesthesiology, General Hospital, trol Dental Devic
Number: K050531
Page 4
§ 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.