(23 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 Latex Examination Gloves
The provided text describes a 510(k) submission for "Powder-free Latex Examination Gloves" by Lovytex Sdn. Bhd. It includes acceptance criteria for the device and a summary of performance data.
Here's an analysis of the provided information, structured as requested:
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 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 | Meets or Exceeds |
| Elongation @ Break - Aged | ASTM D 3578-95 | Meets or Exceeds |
| Water Extractable Protein | ASTM D 5712-95 | 50 $\mu$ grams per gram |
| Cytotoxicity | Not explicitly stated, implied by "NON-TOXIC" | -MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours. |
| Rabbit Skin Irritation | Not explicitly stated, implied by "PASSES" | PASSES |
| Guinea Sensitization Study | Not explicitly stated, implied by "PASSES" | PASSES |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various tests (Water Leak, Residual Powder, Tensile, Elongation, Water Extractable Protein, or biocompatibility tests).
The data provenance is Malaysia, as the applicant is Lovytex Sdn Bhd, located in Selangor Darul Ehsan, Malaysia.
The study appears to be retrospective in the sense that the data is presented as a summary of tests already conducted, presumably as part of the product development and validation process to meet established standards. It's not a prospective, controlled clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The tests refer to compliance with ASTM and FDA standards, which are established protocols, but the details of who performed or verified these tests are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided. The assessment relies on meeting or exceeding established ASTM and FDA standards. There's no mention of a human adjudication process for interpreting the test results beyond the statement that the device "meets or exceeds" the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with evaluating diagnostic imaging tools or AI-assisted diagnostic systems that rely on human-in-the-loop interpretation. The device described is a medical glove, which has different types of performance metrics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in essence, standalone performance was assessed. The tests described (Water Leak, Tensile, Elongation, Water Extractable Protein, Biocompatibility) are objective, laboratory-based physical and chemical tests of the glove itself. These tests measure the inherent properties of the device without human interpretation as part of the performance metric. The "algorithm" here is the physical product and its manufacturing process, and the performance is measured directly against standards.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standards: For mechanical properties (Tensile, Elongation) and some general properties (Water Leak, Residual Powder, Water Extractable Protein).
- FDA Requirements: For pinhole requirements and implied biocompatibility standards.
- Expert Consensus (indirectly): The ASTM standards themselves are developed through expert consensus within the industry.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI development. This device is a physical product (medical glove) and its performance is validated through physical and chemical testing, not through training an algorithm.
9. How the Ground Truth for the Training Set was Established
As the concept of a "training set" doesn't apply, this question is not relevant to the provided document.
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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):
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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.
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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-TOXICat dilution 1:8 at 24 hours.. |
|---|---|
| RABBIT SKIN IRRITATION | - 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.
fi
(Signature)
M. G. Desai
(Typed Name)
2-16-98
(Dated)
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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.
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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
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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
§ 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.