(279 days)
Latex Pationt Examination Glove 80LYY
Not Found
No
The device is a standard patient examination glove and the summary does not mention any AI or ML capabilities.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a preventive measure rather than a therapeutic treatment or therapy for a disease or condition.
No
This device is a patient examination glove, which is a barrier device used to prevent contamination, not to diagnose a condition or disease.
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 to prevent contamination between patient and examiner by being worn on the hands. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Patient Examination Glove," which is a physical barrier device.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on physical properties like watertightness, dimensions, thickness, tensile strength, elongation, powder content, and protein content. These are all related to the glove's function as a physical barrier and its material properties, not to any diagnostic measurement or analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device is a medical device, but it falls under the category of a physical barrier device, not an In Vitro Diagnostic device.
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 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 D3578-01a" and FDA 1000 ml watertight test. The performance data of the glove as showed meet the ASTM D3578-01a" 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 Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Watertight (1000 ml): GI AQL=2.5% Pass GI AQL=2.5%
Length (mm): Min 230 for all sizes. 240 mm minimum for all sizes.
Palm width (mm):
Size XS: 110 mm
Thickness (mm) (Single Layer):
Finger: Min 0.08, 0.10 minimum
Palm: Min 0.08, 0.10 minimum
Physical Properties (Before Aging):
Tensile Strength (Mpa): Min 14.0, 23.9
Ultimate Elongation (%): Min 650, 812
Physical Properties (After Aging):
Tensile Strength (Mpa): Min 14.0, 19.3
Ultimate Elongation (%): Min 500, 741
Powder Content: Below 2mg / glove
Protein Content: Below 50 microgram / gram
Predicate Device(s)
Latex Pationt Examination Glove 80LYY
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.
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DEC 6 2005
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 11, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Polymer Coated Online Chlorinated Powder Free | |
| Latex Examination Gloves | ||
| Common Name | Exam Glove | |
| Classification Name | Latex Patient Examination Glove |
Identification of the Legally Marketed Devices 4.0
Class 1 Latex Pationt Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" 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 O
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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
7. Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01a" and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2 | POLYMER COATED ONLINE CHLORINATED POWDER FREE LATEX EXAM GLOVES | ||
|---|---|---|---|---|
| 1. Watertight (1000 ml) | GI | AQL=2.5% | Pass GI | AQL=2.5% |
| 2. Length (mm) | ||||
| Size XS | ||||
| S | ||||
| M | ||||
| L | ||||
| XL | Min 230 | |||
| Min 230 | ||||
| Min 230 | ||||
| Min 230 | ||||
| Min 230 | 240 mm minimum for | |||
| all sizes | ||||
| 3. Palm width (mm) | ||||
| Size XS | ||||
| S | ||||
| M | ||||
| L | ||||
| XL | - | |||
| 80 +/- 10 | ||||
| 95 +/- 10 | ||||
| 111 +/- 10 |
-
| 110 mm | |
| 4. Thickness (mm)
(Single Layer)
Finger
Palm | | Min 0.08
Min 0.08 | | 0.10 minimum
0.10 minimum |
| 5. Physical Properties
Before Aging
Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14.0
Min 650 | | *23.9
*812 | |
| After Aging
Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14.0
Min 500 | | *19.3
*741 | |
| 6. Powder Content | - | | Below 2mg / glove | |
| 7. Protein Content | - | | Below 50 microgram / gram | |
- The average result obtained from Attachment C.
Page 2 of 3 ATTACHMENT O
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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 D3578-01a" 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 Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves meet the below specifications:
- ASTM D3578-01a'-- Standard -
- -FDA pinhole requirements
- -FDA minimum powder residual content
Page 3 of 3 ATTACHMENT O
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
DEC & 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management Systems Manager SPI Gloves Sdn. Bhd 5, Persiaran Greentown 8, Greentown Business Center, 30450 Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K050526
Trade/Device Name: Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 24, 2005 Received: November 28, 2005
Dear Ms. 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. 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 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/industry/support/index.html.
Sincercly yours,
Snette y. Michael Ons.
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
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INDICATIONS FOR USE STATEMENT
Applicant : SPI Gloves Sdn. Bhd.
510(K) Number :
- Device Name : Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 micrograms or less of Total Water Extractable Protein per Gram)
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
ાર
Over-The-Counter ..... X ..........
Shida A. Humphrey, MD 12/6/05
A050526
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