(39 days)
Not Found
Not Found
No
The device is a standard patient examination glove and the summary contains no mention of AI or ML capabilities.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and does not provide therapeutic benefit.
No
The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination.
- Device Description: The description details a "Class 1 Polymer Coated Patient Examination Glove." This is a physical product, not a reagent, instrument, or system used to examine specimens derived from the human body.
- Lack of IVD Characteristics: The description and performance data focus on physical properties (watertightness, dimensions, tensile strength, etc.) and biocompatibility. There is no mention of analyzing specimens, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications 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.
Product codes
LYY
Device Description
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D3578-00a and FDA 1000 ml watertight test.
TEST: Watertight (1000 ml), ASTM D3578-00a: GI AQL=4.0%, CASHMERE POWDER FREE LATEX EXAM GLOVES: Pass GI AQL=4.0%
TEST: Length (mm), ASTM D3578-00a: Min 230 for all sizes, CASHMERE POWDER FREE LATEX EXAM GLOVES: 240 mm minimum for all sizes
TEST: Palm width (mm), ASTM D3578-00a: Size XS -, S 80 +/- 10, M 95 +/- 10, L 111 +/- 10, XL -, CASHMERE POWDER FREE LATEX EXAM GLOVES: XS 75 - 78, S 82 - 88, M 92 - 98, L 102 - 108, XL 111 - 115
TEST: Thickness (mm) (Single Layer) Finger, ASTM D3578-00a: Min 0.08, CASHMERE POWDER FREE LATEX EXAM GLOVES: 0.10 minimum
TEST: Thickness (mm) (Single Layer) Palm, ASTM D3578-00a: Min 0.08, CASHMERE POWDER FREE LATEX EXAM GLOVES: 0.10 minimum
TEST: Physical Properties Before Aging Tensile Strength (Mpa), ASTM D3578-00a: Min 14, CASHMERE POWDER FREE LATEX EXAM GLOVES: 25.1
TEST: Physical Properties Before Aging Ultimate Elongation (%), ASTM D3578-00a: Min 650, CASHMERE POWDER FREE LATEX EXAM GLOVES: 940
TEST: Physical Properties After Aging Tensile Strength (Mpa), ASTM D3578-00a: Min 14, CASHMERE POWDER FREE LATEX EXAM GLOVES: 18
TEST: Physical Properties After Aging Ultimate Elongation (%), ASTM D3578-00a: Min 500, CASHMERE POWDER FREE LATEX EXAM GLOVES: 950
TEST: Powder Content, ASTM D3578-00a: -, CASHMERE POWDER FREE LATEX EXAM GLOVES: Below 2 mg / glove
TEST: Protein Content, ASTM D3578-00a: -, CASHMERE POWDER FREE LATEX EXAM GLOVES: Below 50 microgram / gram
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 1 0 2002
K024 388
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHD |
| Lot 72706, Jalan Lahat | ||
| Kawasan Perindustrian Bukit Merah | ||
| 31500 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 | March 27, 2002 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Powder Free Latex Examination Gloves | |
| Common Name | Exam Glove | |
| Classification Name | Patient Examination Glove |
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 D3578-00a 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 D3578-00a 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 M
1
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my
Summary of Performance Data : 7.
Performance data of gloves based on ASTM D3578-00a and FDA 1000 ml watertight test.
| TEST | ASTM D3578-00a | CASHMERE POWDER
FREE LATEX EXAM
GLOVES |
|----------------------------------------|----------------|----------------------------------------------|
| 1. Watertight (1000 ml) | GI
AQL=4.0% | Pass GI
AQL=4.0% |
| 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 | - | 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 Properties | | |
| Before Aging
Tensile Strength (Mpa) | Min 14 | 25.1 |
| Ultimate Elongation (%) | Min 650 | 940 |
| After Aging
Tensile Strength (Mpa) | Min 14 | 18 |
| Ultimate Elongation (%) | Min 500 | 950 |
| 6. Powder Content | - | Below 2 mg / glove |
| 7. Protein Content | - | Below 50 microgram / gram |
Page 2 of 3 ATTACHMENT M
2
SEAL POLYMER INDUSTRIES SDN, BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605-3222 300 E-mail: spoly@po.jaring.my
-
- The performance data of the glove as showed above meet the ASTM D3578-00a Standard and FDA's requirement. Powder content is below 2 mg per glove that meets 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 Powder Free Latex Examination Gloves meet:
- -ASTM D3578-00a Standard
- FDA pinhole requirements r
- FDA minimum powder residual content -
Page 3 of 3 ATTACHMENT M
3
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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
JUN 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chun Chooi Fong Quality Assurance Manager Seal Polymer Industrial Sdn. Bhd. Lot 72706. Jalan Lahat, Kawasan Perindustrian Bukit Merah Lahat, Perak, MALAYSIA 31500
Re: K021388
Trade/Device Name: Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 30, 2002 Received: June 5, 2002
Dear Mr. 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.
4
Page 2 - Mr. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timot A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
Applicant : Seal Polymer Industries Sdn. Bhd.
510(K) Number: K021388
- Device Name : Cashmere Powder Free Latex Examination Gloves With Protein Labeling Claim (50 micrograms or less) & Total Unter Extress & Later & Claim
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
OR
Over-The-Counter ... ....................
Qia S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _