LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES

K980618 · Lovytex Sdn Bhd · LYY · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K980618
• Device Name: LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
• Applicant: Lovytex Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.

Device Story

Powder-free natural latex examination gloves; worn on hands by healthcare personnel; acts as physical barrier to prevent cross-contamination between clinician and patient; tested for water leak, residual powder, tensile strength, elongation, and protein content; biocompatibility verified via cytotoxicity, skin irritation, and sensitization testing.

Clinical Evidence

Bench testing only. Device meets or exceeds ASTM D 3578-95 standards for tensile strength and elongation (unaged and aged), water leak requirements, and residual powder limits. Biocompatibility testing (MEM cytotoxicity, rabbit skin irritation, guinea pig sensitization) passed.

Technological Characteristics

Material: Natural latex. Form factor: Powder-free examination glove. Standards: ASTM D 3578-95 (physical properties), ASTM D 5712-95 (protein content). Protein content: 50 micrograms per gram. Biocompatibility: Non-toxic (MEM test), non-irritating, non-sensitizing.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the personnel and the patient.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 [phone] 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-TOXIC<br>at 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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