(44 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and safety of a medical glove, with no mention of AI or ML technology.
No
The device, a medical glove, is intended to prevent contamination and does not directly treat or diagnose a disease or condition in a patient.
No
A medical glove is used to prevent contamination, not to detect or diagnose a medical condition. Its function is protective.
No
The device is a physical medical glove, not a software application. The description clearly outlines a hardware product and its performance characteristics related to physical properties.
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 healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a medical glove, which is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
80LZA
Device Description
Product Code: Nitrile . 80LZA Device Class: Class 1
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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)
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.
CYTOTOXICITY -MEM test extract was NON-TOXIC at dilution 1:4 at 24 hours.
RABBIT SKIN IRRITATION - PASSES
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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 Device
Performance | Predicate Devices
Performance |
|-----------------|--------------------|-------------------------------|----------------------------------|
| 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 |
2
| Characteristic | Reference Document | Lovytex Device
Performance | Predicate Devices *
Performance |
|--------------------|--------------------|----------------------------------------------------|-----------------------------------------------------|
| Elongation @ Break | | | |
| - Unaged | ASTM D 3578-95 | Does not meet; BUT
meets ASTM D 5250
(Vinyl) | Does not meet;
BUT meets ASTM
D 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-TOXIC
at dilution 1:4 at 24 hours. |
|------------------------|-----------------------------------------------------------------|
| RABBIT SKIN IRRITATION | - PASSES |
3
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)
4
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
5
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
6
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