(44 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 Nitrile Examination Gloves
This document is a 510(k) submission for Lovytex Powder-free Nitrile Examination Gloves (K981179). The acceptance criteria and the study proving the device meets them are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Reference Document) | Reported Device Performance (Lovytex Device) |
|---|---|---|
| Water Leak | ASTM D 3578 / FDA | Meets or Exceeds |
| Residual Powder | ASTM DRAFT / FDA | 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 | Does not meet ASTM D 3578-95; BUT meets ASTM D 5250 (Vinyl) |
| Elongation @ Break (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Pinhole Requirements | FDA | Meets |
| Cytotoxicity | -MEM test | Non-toxic at dilution 1:4 at 24 hours |
| Rabbit Skin Irritation | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, the tests are laboratory-based performances of the glove material. The manufacturer is Lovytex Sdn Bhd, located in Malaysia, suggesting the testing was likely conducted in Malaysia. The studies are prospective as they are tests performed on the Lovytex device to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics of examination gloves is established by standardized testing protocols (e.g., ASTM standards, FDA pinhole requirements) and general biocompatibility assessments, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective laboratory measurements against set standards, not by an adjudication process involving human review of cases.
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 diagnostic devices that involve human interpretation of images or other data. For examination gloves, the focus is on material properties and barrier integrity, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted are standalone evaluations of the device's physical and biological properties. There is no "algorithm" or human-in-the-loop component for examination gloves. The device's performance is assessed purely on its inherent characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Standardized Test Methods: Adherence to established industry standards like ASTM D 3578-95 for physical properties (e.g., tensile strength, elongation).
- Regulatory Requirements: Meeting FDA specific requirements, such as pinhole acceptance rates.
- Biocompatibility Testing: Results from established biological evaluation methods for medical devices (e.g., cytotoxicity tests, skin irritation tests).
8. The Sample Size for the Training Set
This concept is not applicable here. There is no "training set" for physical and biocompatibility testing of examination gloves as there is no machine learning or AI algorithm being developed. The tests are performed on representative samples of the manufactured gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved in this type of device submission.
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18.0 510 (k) SUMMARY
MAY 1 5 1998
1. Submission Applicant
Name:
Street Address: Lot 8, Jalan Suasa , 42500 Telok Panglima Garang ,
Selangor Darul Ehssn Country Malaysia _____________________________________________________________________________________________________________________________________________________________
Phone No _ + 6-03-352 7402 ___________________________________________________________________________________________________________________________________________________ FAX No +6-03-352 7733
Contact Person: M.G. Desai
8040475 ______________________________________________________________________________________________________________________________________________________________________
[Registration Number, Form 2891(a)]
A 444401
(Device Listing Number, Form 2892)
Activity:
[ X ] Manufacturer
| Applicant Lovytex Sdn Bhd | ||
|---|---|---|
| 510(k) Number (if known): | K981179 |
2. Device Particulars
Device Name: Powder-free Nitrile Examination Gloves Trade/Proprietary Name: Lovytex Powder-free Nitrile Examination Gloves Common Name: Powder-free Examination Gloves Classification Name: Patient Examination Gloves
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3. Device Classification
Device Class: Class 1
Product Code: Nitrile . 80LZA
4. Predicate Devices
-
- Pure Advantage Powder-free Nitrile Examination Gloves ; Tillotson Healthcare Corporation
- Safeskin Nitrile Examination Gloves ; Safeskin Corporation
5. Device Description
Product Code: Nitrile . 80LZA Device Class: Class 1
6. 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.
7. Comparison of Characteristics to Predicate Devices
| Characteristic | Reference Document | Lovytex DevicePerformance | Predicate DevicesPerformance |
|---|---|---|---|
| Water Leak | ASTM D 3578/FDA | Meets or Exceeds | Meets or Exceeds |
| Residual Powder | ASTM DRAFT/FDA | Meets or Exceeds | Meets or Exceeds |
| Tensile | |||
| - Unaged | ASTM D 3578-95 | Meets or Exceeds | Meets or Exceeds |
| - Aged | ASTM D 3578-95 | Meets or Exceeds | Meets or Exceeds |
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| Characteristic | Reference Document | Lovytex DevicePerformance | Predicate Devices *Performance |
|---|---|---|---|
| Elongation @ Break | |||
| - Unaged | ASTM D 3578-95 | Does not meet; BUTmeets ASTM D 5250(Vinyl) | Does not meet;BUT meets ASTMD 5250 (Vinyl ) |
| - Aged | ASTM D 3578-95 | Meets or Exceeds | Meets or Exceeds |
-
- Tillotson Healthcare Corporation's "Pure Advantage" nitrile examination gloves
- Safeskin Corporation's "Safeskin" nitrile examination gloves.
The "Pure Advantage" and "Safekin" gloves are however also labelled "HYPOALLERGENIC"; the subject device SHALL NOT include the "hypoallergenic" label in the packaging .
7. Assessment of Non-Clinical Performance Data
The device :-
- meets or exceeds the ASTM standard or equivalent standard EXCEPT in so far as Elongation @ Break (Unaged) where it meets the reguirments of ASTM 5250 applicable for Vinyl gloves .
- meets FDA pinhole requirements.
8. Assessment of Biocompatibility Performance Data
| CYTOTOXICITY | -MEM test extract was NON-TOXICat dilution 1:4 at 24 hours. |
|---|---|
| RABBIT SKIN IRRITATION | - PASSES |
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Lovytex Sdn. Bhd.
(Company No. 52031-D) Lot 8, Jalan Suasa, 42500 Telok Panglima Gara Kuala Langat, Selangor Darul Ehsan, Malaysia Tel: 603-3526711 Fax: 603-3527733
9. CONCLUSIONS OF NON-CLINICAL & BIOCOMPATIBILITY PERFORMANCE DATA
The device has been carefully compared to legally marketed devices in the 510(k). The data summaries indicate that the proposed device meets or exceeds all acceptable scores for the predicate Nitrile 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.
fi
(Signature)
M. G. Desai
(Typed Name)
(Dated)
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three wavy lines representing the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 5 1998
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 : K981179 Trade Name: Lovytex Powder-Free Nitrile Examination Gloves Regulatory Class: I Product Code: LZA Dated: March 27, 1998 Received: April 1, 1998
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 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 Requlations, 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 Regulation (QS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Desai
through 542 of the Act for devices under the Electronic Product Radiation 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 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 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 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/dsma/dsmama4n.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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Indication For Use 3.0
INDICATION FOR USE
Applicant : Lovytex Sdn Bhd 9811199 * 510(k) Number (if known): _
Device Name: Powder-free Nitrile Examination Gloves
Indication For Use:
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
. . . .
Chia S. Lin
(optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K981179
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.