(62 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-free Polymer Coated Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Reference Document) | Reported Device Performance |
|---|---|---|
| Water Leak | ASTM D 3578/FDA | Meets or Exceeds |
| Residual Powder | ASTM D 6124 | Meets or Exceeds |
| Tensile (Unaged) | ASTM D 3578-95 | Meets or Exceeds |
| Tensile (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Elongation @ Break (Unaged) | ASTM D 3578-95 | Meets or Exceeds |
| Elongation @ Break (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Water Extractable Protein | ASTM D 5712-95 | 50 u grams per gram |
| Cytotoxicity | (Not explicitly stated, but implied by "MEM test extract was NON-TOXIC") | MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours. |
| Rabbit Skin Irritation | (Not explicitly stated, but implied by "PASSES") | PASSES |
| Guinea Sensitization Study | (Not explicitly stated, but implied by "PASSES") | PASSES |
| Pinhole Requirements | FDA Pinhole Requirements | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics (e.g., water leak, tensile strength, protein content, biocompatibility tests).
The data provenance is retrospective, as this is a 510(k) submission summarizing data already collected. The country of origin of the data is implicitly Malaysia, given that the applicant, Lovytex Sdn Bhd, is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For performance tests on examination gloves, the "ground truth" is typically established by the standardized testing methodologies themselves (e.g., ASTM standards) rather than by human expert consensus or interpretation of images. Biocompatibility tests are also performed by trained laboratory personnel following specific protocols.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies. For objective performance tests of physical properties and chemical composition, such adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being assessed. This submission is for an examination glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This question is not applicable to an examination glove. This is not an AI-driven device with an algorithm that performs tasks independently. The performance listed is that of the physical product itself.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements against established industry standards and regulatory requirements. Specifically:
- ASTM (American Society for Testing and Materials) standards for physical properties (Water Leak, Residual Powder, Tensile, Elongation @ Break, Water Extractable Protein).
- FDA Pinhole requirements.
- Biocompatibility test results (Cytotoxicity, Rabbit Skin Irritation, Guinea Sensitization Study) which have defined pass/fail criteria.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a "training set." The product's properties are inherent to its manufacturing process and materials.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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Kg84147
(Company No. 52031-D) Lot 8, Jalan Suasa, 42500 Telok Panglima Garang, Kuala Langat, Selangor Darul Ehsan, Malaysia. Tel: 603-3526711 Fax: 603-3527733
JAN 20 1999
510 (k) SUMMARY
1. Submission Applicant
Name:
Street Address: _ Lot 8, Jalan Suasa ,42500 Telok Panglima Garang ,
Country Malaysia Selangor Darul Ehssn
Phone No _ + 6-03-352 7402 FAX No +6-03-352 7733
Contact Person: M.G. Desai
8040475
A 444401
[Registration Number, Form 2891(a)]
(Device Listing Number, Form 2892)
Activity:
[ X ] Manufacturer
Applicant Lovytex Sdn Bhd K 98 4147 ★ 510(k) Number (if known): __
2. Device Particulars
Device Name: Powder-free Polymer Coated Latex Examination Gloves
with protein label claim 50 micro-grams per gram
Trade/Proprietary Name: N/A
Common Name: Powder-free Examination Gloves
Classification Name: Patient Examination Gloves
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3. Device Classification
Device Class: Class 1
Product Code: Latex (Powder-free). 80LYY
4. Device Description
Product Code: Latex (Powder-free). 80LYY Device Class: Class 1
5. Summary of Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
6. Summary of Technological Characteristics
| Characteristic | Reference Document | Device Performance |
|---|---|---|
| Water Leak | ASTM D 3578/FDA | Meets or Exceeds |
| Residual Powder | ASTM D 6124 | Meets or Exceeds |
| Tensile | ||
| - Unaqed | ASTM D 3578-95 | Meets or Exceeds |
| - Aged | ASTM D 3578-95 | Meets or Exceeds |
| Elongation @ Break | ||
| - Unaged | ASTM D 3578-95 | Meets or Exceeds |
| - Aged | ASTM D 3578-95 | Meets or Exceeds |
| Water Extractable Protein | ASTM D 5712-95 | 50 u grams per gram |
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L984147
7. Assessment of Non-Clinical Performance Data
The device :-
- meets or ecxeeds the ASTM standard or equivalent standard
- meets FDA pinhole requirements; and
- meets the labelling claim as shown by the data in Section 6 above.
8. Assessment of Biocompatibility Performance Data
SUMMARY OF RESULTS OF BIOCOMPATIBILITY TESTS
CYTOTOXICITY
RABBIT SKIN IRRITATION
-MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours.. - PASSES
GUINEA SENSITIZATION STUDY - PASSES
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9. CONCLUSIONS OF NON-CLINICAL & BIOCOMPATIBILITY PERFORMANCE DATA
The device has been carefully compared to existing performance criteria of the ASTM and FDA to which all legally marketed devices are required to be compared. The data summaries indicate that the proposed device meets or exceeds all acceptable scores and satisfies all requirements for powder-free natural latex examination gloves.
Pursuant to 21 CFR 807.87 (j), I M.G. Desai, the Chief Executive Officer of Lovytex Sdn Bhd, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Chief Executive Officer of Lovytex Sdn Bhd, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.
ti
(Signature)
M. G. Desai
(Typed Name)
11-16-98
(Dated)
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Image /page/4/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 symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Mr. M.G. Desai Chief Executive Officer Lovytex Sdn. Bhd. (Company No. 52031-D) Lot #8, Jalan Suasa 42500 Telok Panglima Garang, Kuala Langat, Selangor Darul Ehsan, MALAYSIA
Re : K984147 Lovytex Powder-Free Polymer Coated Latex Trade Name: Examination Glove with Protein Content of Labeling Claim (50 micrograms or less) Requlatory Class: I Product Code: LYY November 16, 1998 Dated: November 19, 1998 Received:
Dear Mr. Desai:
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 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). 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 reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Desai
this response to your premarket notification submission does chis response to your promon might have under sections 531 through 542 of the Act for devices under the Electronic enrough Sri or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in four and equivalence of your device to a legally marketed predicate device results in a classification for your marrice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directpr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Indication For Use
INDICATION FOR USE
Applicant : Lovytex Sdn Bhd
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Powder-free Polymer Coated Latex Examination Gloves
with protein label claim 50 micro-grams per gram.
Indication For Use:
1 : .........
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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter X
Per 21 CFR 801.109
(optional Format 1-2-96)
Olin Silon
Division Sign-Off) Division of Dental, Infestiga Comfrol; and General Hospital Devices 510(k) Number
CONFIDENTIAL- DO NOT COPY
§ 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.