(44 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
The provided documentation describes the acceptance criteria and performance of the "Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves." This is a Class I medical device, and the evaluation is based on established ASTM standards and FDA requirements for such gloves, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., test set sample size, expert ground truth, MRMC study, standalone performance, training set) are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (Cashmere Polymer Coated Powder Free Latex Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | G I, AQL=4.0% | Pass GI, AQL=4.0% |
| 2. Length (mm) | Min 230 mm (all sizes) | 240 mm minimum for all sizes |
| - Size XS | Min 230 | 240 mm |
| - Size S | Min 230 | 240 mm |
| - Size M | Min 230 | 240 mm |
| - Size L | Min 230 | 240 mm |
| - Size XL | Min 230 | 240 mm |
| 3. Palm width (mm) | ||
| - Size XS | - | 75 - 78 |
| - Size S | 80 +/- 10 | 82 - 88 |
| - Size M | 95 +/- 10 | 92 - 98 |
| - Size L | 111 +/- 10 | 102 - 108 |
| - Size XL | - | 111 - 115 |
| 4. Thickness (mm) | ||
| - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| 5. Physical Properties | ||
| Before Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 16.5 |
| - Ultimate Elongation (%) | Min 700 | 550 |
| After Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 23.1 |
| - Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - (No specific ASTM value provided) | Below 2 mg / glove |
| 7. Protein Content | - (No specific ASTM value provided) | Below 70 microgram / gram |
2. Sample size used for the test set and the data provenance
The document states that performance data is based on "ASTM D3578-95 and FDA 1000 ml watertight test." These standards specify sampling plans (e.g., AQL for watertightness), but the exact sample sizes used for this specific submission are not explicitly provided in the excerpt. The data provenance is for a manufacturing company located in Malaysia (SEAL POLYMER INDUSTRIES SDN. BHD., Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, Malaysia). The nature of these tests (physical and chemical properties) indicates a prospective evaluation of manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical glove, and its performance is evaluated against objective physical and chemical standards (ASTM D3578-95, FDA watertight test). It does not involve expert interpretation or ground truth establishment in the context of diagnostic AI/ML devices.
4. Adjudication method for the test set
Not applicable. Device performance is measured against quantifiable standards for physical and chemical properties.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is objective measurement against established industry and regulatory standards. For example, for "Watertightness," the ground truth is whether the glove passes the FDA's 1000 ml watertight test at an AQL of 4.0%. For dimensions, it's the measured length and width compared to the specified range. For physical properties, it's the measured tensile strength and elongation compared to minimum requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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
Attachment L
| 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 | Mr. CHAN CHIN HONG | |
| Date of Summary Prepared | September 20, 1999 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Non-Sterile, Polymer Coated Powder FreeLatex Examination Gloves | |
| Common Name | Exam Glove | |
| Classification Name | Polymer Coated Powder Free Patient ExaminationGlove |
4.0 Identification of The Legally Marketed Devices
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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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
Attachment L
7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-95 | CASHMERE POLYMERCOATED POWDER FREELATEX EXAM GLOVES |
|---|---|---|
| 1. Watertight (1000 ml) | G IAQL=4.0% | Pass GIAQL=4.0% |
| 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 | - | 75 - 78 |
| S | 80 +/- 10 | 82 - 88 |
| M | 95 +/- 10 | 92 - 98 |
| L | 111 +/- 10 | 102 - 108 |
| XL | - | 111 - 115 |
| 4. Thickness (mm)(Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical PropertiesBefore Aging | ||
| Tensile Strength (Mpa) | Min 14 | 16.5 |
| Ultimate Elongation (%) | Min 700 | 550 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - | Below 2 mg / glove |
| 7. Protein Content | - | Below 70 microgram / gram |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1999
Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia
Re : K993326 Non-sterile Polymer Coated Powder Free Latex Trade Name: Examination Gloves with a Protein Labeling Claim (70 micrograms or less per gram) Requlatory Class: I Product Code: LYY Dated: September 29, 1999 October 4, 1999 Received:
Dear Mr. Hong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Hong
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
Kga 3326 510(K) Number :
Prescription Use: ......................................
Per 21 CFR 80.109
: Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination, Device Name Cloves, Contains 70 microgram on less of Total rofa
Indication For Use:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
| Concurrence of CDRH Office of Device Evaluation (ODC) | ||||||
|---|---|---|---|---|---|---|
..............................................................................................................................................................................
Chun S. Lin
OR
Over-The-Counter ... ... .................
(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
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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.