(43 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.
The device being discussed is "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)". The study conducted to prove the device meets acceptance criteria is based on the performance data of the gloves according to ASTM D6319-00a3 standards and the FDA 1000 ml watertight test, as well as biocompatibility tests.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test/Characteristic | Acceptance Criteria (ASTM D6319-00a3) | Reported Device Performance (Cashmere Powder Free Nitrile Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | G I, AQL=2.5% | Pass G I, AQL=2.5% |
| Length (mm) - All Sizes | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) - Size XS | - | <80 |
| Palm width (mm) - Size S | 80 +/- 10 | 82 - 88 |
| Palm width (mm) - Size M | 95 +/- 10 | 92 - 98 |
| Palm width (mm) - Size L | 111 +/- 10 | 102 - 108 |
| Palm width (mm) - Size XL | - | >110 |
| Thickness (mm) - Finger | Min 0.08 | 0.08 minimum |
| Thickness (mm) - Palm | Min 0.08 | 0.08 minimum |
| Before Aging: Tensile Strength (Mpa) | Min 14.0 | 23.9* |
| Before Aging: Ultimate Elongation (%) | Min 500 | 760* |
| After Aging: Tensile Strength (Mpa) | Min 14.0 | 24.3* |
| After Aging: Ultimate Elongation (%) | Min 400 | 640* |
| Powder Content | - (FDA Requirement) | Below 2mg / glove |
| Biocompatibility | Pass (implied by FDA review) | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test |
- Indicates average results from Attachment B2, which is not provided in the document.
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 does not explicitly state the specific sample sizes for each test in the provided performance data. However, for the "Watertight (1000 ml)" test, an AQL (Acceptable Quality Level) of 2.5% is mentioned, which implies a sampling plan was used according to ASTM D6319-00a3.
The data provenance is from Malaysia, where Seal Polymer Industries SDN. BHD. is located. It is
prospective testing conducted by the manufacturer to demonstrate compliance with standards.
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 is not applicable as the device is a medical glove, and the "ground truth" is established by adherence to physical and chemical standards and biocompatibility tests, not subjective expert evaluation of medical images or conditions. The standards themselves (ASTM D6319-00a3 and FDA requirements) define the objective criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements based on established standards, not subjective interpretations 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 is not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-enabled diagnostic device. The performance data presented refers to the physical and chemical properties of the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established industry standards and regulatory requirements:
- ASTM D6319-00a3 Standard: Defines the physical properties and performance requirements for nitrile examination gloves.
- FDA 1000 ml watertight test: A specific regulatory requirement for barrier integrity.
- FDA minimum powder residual content: A specific regulatory limit for powder on gloves.
- Biocompatibility test results: Objective laboratory tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the material's interaction with biological systems.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training paradigm.
9. How the ground truth for the training set was established
Not applicable, as no training set is relevant for this device.
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AUG 1 9 2003
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHDLot 72706, Jalan LahatKawasan Perindustrian Bukit Merah31500 Lahat, Perak, Malaysia |
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | July 01, 2003 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Non-Sterile, Powder Free NitrileExamination Gloves (Violet) | |
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
4.0 ldentification of the Legally Marketed Devices
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.
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SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Summary of Performance Data: 7.
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D6319-00a3 | CASHMERE POWDER FREE NITRILE EXAM GLOVES | |
|---|---|---|---|
| 1. Watertight (1000 ml) | G IAQL=2.5% | Pass GI | AQL=2.5% |
| 2. Length (mm)Size XS | Min 230 | 240 mm minimum for all sizes | |
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | Min 230 | ||
| 3. Palm width (mm)Size XS | - | <80 | |
| S | 80 +/- 10 | 82 - 88 | |
| M | 95 +/- 10 | 92 - 98 | |
| L | 111 +/- 10 | 102 - 108 | |
| XL | - | >110 | |
| 4. Thickness (mm)(Single Layer) | |||
| Finger | Min 0.08 | 0.08 minimum | |
| Palm | Min 0.08 | 0.08 minimum | |
| 5. Physical Properties | |||
| Before AgingTensile Strength (Mpa) | Min 14.0 | 23.9* | |
| Ultimate Elongation (%) | Min 500 | 760* | |
| After AgingTensile Strength (Mpa) | Min 14.0 | 24.3* | |
| Ultimate Elongation (%) | Min 400 | 640* | |
| 6. Powder Content | - | Below 2mg / glove |
- indicates the average results from Attachment B2.
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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
- The performance data of the glove as showed above meet the ASTM D6319-00a" 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 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves meet:
- ASTM D6319-00a53 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content -
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2003
Mr. Chun Chooi Fong Quality Assurance Department Manager Seal Polymer Industries SDN. BHD. Lot 72706, Jalan, Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia
Re: K032077
Trade/Device Name: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 1, 2003 Received: July 7, 2003
Dear Mr. 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 - Mr. 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 (301) 594-4618. 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/dsmamain.html
Sincerely wours,
the proving Sharr Susan Runner, DDS, MA Interim 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 STATEMENT
Applicant : Seal Polymer Industries Sdn. Bhd.
| 510(K) Number : | K032077 |
|---|---|
| ----------------- | --------- |
Device Name : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)
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.
Qim S. him
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number: K032027
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ... ... ... ... ... .............. Per 21 CFR 80.109
OR
Over-The-Counter ... ... ... ... ... ......
§ 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.