(23 days)
Not Found
Not Found
No
The device is a medical glove and the description and performance metrics relate to physical properties and standards, not AI/ML functionality.
No
A medical glove is used for prevention and protection against contamination, not for treating a disease or condition.
No
The device, a medical glove, is intended to prevent contamination and is not used to diagnose a medical condition or disease.
No
The device description clearly states "Powder-free Latex Examination Gloves," indicating a physical hardware device, not software.
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 function.
- Device Description: It's described as "Powder-free Latex Examination Gloves," which are physical barriers.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Metrics: The performance metrics listed (Water Leak, Tensile, Elongation, Protein) relate to the physical properties and integrity of the glove, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This glove does not perform such a function.
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)
80LYY
Device Description
Product Code: Latex (Powder-free). 80LYY 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 ecxeeds the ASTM standard or equivalent standard
- meets FDA pinhole requirements; and
- meets the labelling claim as shown by the data in Section 6.
SUMMARY OF RESULTS OF BIOCOMPATIBILITY TESTS
CYTOTOXICITY -MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours.
RABBIT SKIN IRRITATION - PASSES
GUINEA SENSITIZATION STUDY - 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
ovytex Sdn. Bhd.
(Company No. 52031-D) Lot 8, Jalan Suasa, 42500 Telok Panglima Garang, Kuala Langat, Selangor Darul Ehsan, Malaysia. Tel: 603-3526711 Fax: 603-3527733
K98061d
MAR 1 3 100R
510 (k) SUMMARY
1. Submission Applicant
Lovytex Sdn Bhd Name: ________________________________________________________________________________________________________________________________________________________________________ Street Address: _ Lot 8, Jalan Suasa ,42500 Telok Panglima Garang , Country Malaysia Selangor Darul Ehssn
FAX No +6-03-352 7733 Phone No
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 98,06 510(k) Number (if known):
1
2. Device Particulars
Device Name: Powder-free Latex Examination Gloves Trade/Proprietary Name: N/A Common Name: Powder-free Examination Gloves Classification Name: Patient Examination Gloves
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.
2
6. Summary of Technological Characteristics
| Characteristic | Reference Document | Device Performance |
|---|---|---|
| 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 |
| - 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 $\mu$ grams per gram |
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.
8. Assessment of Biocompatibility Performance Data
SUMMARY OF RESULTS OF BIOCOMPATIBILITY TESTS
| CYTOTOXICITY | -MEM test extract was NON-TOXIC
at dilution 1:8 at 24 hours.. |
|----------------------------|------------------------------------------------------------------|
| RABBIT SKIN IRRITATION | - PASSES |
| GUINEA SENSITIZATION STUDY | - PASSES |
3
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.
fi
(Signature)
M. G. Desai
(Typed Name)
2-16-98
(Dated)
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. M. G. Desai Chief Executive Officer Lovytex Sdn. Bhd. Lot #8 Jalan Suasa Telok Panqlima Garang Selangor Darul Ehsan Malaysia
K980618 Re : Lovytex Sdn Bdh Powder-Free Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (50 microgram per gram) Regulatory Class: I Product Code: LYY February 16, 1998 Dated: February 18, 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 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 The general controls provisions of the Act 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).cor 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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
5
Page 2 - Mr. Desai
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents response or light on you might have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz 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 finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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) 594-4618. 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 one rogandon" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy J. Ulstanski
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 |
|---|---|
| 510(k) Number (if known): | K980618 * |
| Device Name: | Powder-free Latex Examination Gloves with protein label claim |
(50 microgram per glove)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
Per 21 CFR 801.109
510(k) Number _
(optional Format 1-2-96)
(Division Sigr
Division of Del.:
and General Hospiat
Thin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control. and General Hospital
510(k) Number K980618
CONFIDENTIAL- DO NOT COPY
ਤੇ