GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)

K994426 · Pt. Wrp Buana Multicorpora · LYY · May 23, 2000 · General Hospital

Device Facts

• Record ID: K994426
• Device Name: GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
• Applicant: Pt. Wrp Buana Multicorpora
• Product Code: LYY · General Hospital
• Decision Date: May 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

Device Story

Glovetex Examination Gloves are non-sterile, powdered latex gloves. Designed for use by healthcare personnel to provide a barrier against contamination between the wearer and the patient's body, fluids, waste, or environment. The device is a disposable, single-use physical barrier. It functions by covering the hand/fingers of the clinician during examinations. The device benefits patients and clinicians by reducing the risk of cross-contamination during medical procedures. No electronic, software, or algorithmic components are involved.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D 3578-99 and FDA 1000 ml watertight test. Key metrics: Watertight AQL 1.5; Tensile strength (before aging) 21 MPa min; Ultimate elongation (before aging) 700% min; Protein content < 100 µg/g per ASTM D 5712-95.

Technological Characteristics

Material: Latex. Form factor: Powdered, non-sterile examination glove. Dimensions: XS, S, M, L sizes with specified palm widths and thickness (0.08 mm min). Standards: ASTM D 3578-99 (physical properties), ASTM D 5712-95 (protein content). No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between examiner and patient. Suitable for healthcare personnel and similar personnel.

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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Image /page/0/Picture/0 description: The image shows the logo for PT WRP Buana Multico. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a rounded shape. To the right of the logo is the text "PT WRP Buana Multico", with the last part of the text being partially obscured.

Jalan Jermal, No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

TEL [phone] [phone] FAX [phone] URL www.wrpworld.com

**510(K) SUMMARY** K9946

- 1. Trade Name : Glovetex Examination Gloves, Powdered Non-Sterile ( Protein Cont
(Protein Content Labeling)
(100 MICROGRAMS or LESS)

- 2. Common Name : Examination Gloves
MAY 2 3 2000

- 3. Classification Name : Patient Examination Glove
#### 4. Substantial Equivalence :

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

- ട്. Description of Device :
Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

- 6. Intended use of Device :
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

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## 7. Summary of Performance Data :

Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test.

| | TEST | ASTM D 3578 - 99 | In-house Specification for |
|----|-----------------------------------------|------------------|-------------------------------------------------------|
| | | | Glovetex Examination Gloves,<br>Powdered, Non-Sterile |
| | | | ( Protein Content Labeling ) |
| 1. | Watertight (1000 ml) | G-1 ; AQL 2.5 | G-1 ; AQL 1.5 |
| 2. | Length ( mm) | | |
| | Size<br>XS | | |
| | S | 220 Min. | 230 Min. |
| | M | 230 Min. | 230 Min. |
| | L | 230 Min. | 230 Min. |
| | XL | | |
| 3. | Palm Width (mm) | | |
| | Size<br>XS | | |
| | S | $80 \pm 10$ | $80 \pm 10$ |
| | M | $95 \pm 10$ | $95 \pm 10$ |
| | L | $111 \pm 10$ | $111 \pm 10$ |
| | XL | | |
| 4. | Thickness (mm) | | |
| | Palm | 0.08 Min. | 0.08 Min. |
| | Finger | 0.08 Min. | 0.08 Min. |
| 5. | Physical Properties.<br>Before Ageing : | S-2 ; AQL 4.0 | S-2 ; AQL 4.0 |
| | - Tensile Strength (MPa) | 14 MPa Min. | 21 MPa Min. |
| | - Ultimate Elongation (%) | 700% Min. | 700% Min. |
| | After Ageing : | | |
| | - Tensile Strength (MPa) | 14 MPa Min. | 16 MPa Min. |
| | - Ultimate Elongation (%) | 500% Min. | 500% Min. |
| 6. | Powder Content. | - | Below 110 mg/glove |
| 7. | Moisture Content. | - | 0.8 Max. |
| 8. | Protein Content. | - | Below 100 µg/g |

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# Substantial Equivalence Based on Assessment of Non-Clinical Performance Data : 8.

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578 - 99.

Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95 below 100 µg/g.

### 9. Conclusion.

The gloves that is to be marketed meets all the requirements of ASTM D 3578-99 and has a low detectable level of protein ( of about < 100 µg/g ).

Summarised on : December 21st, 1999

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Ng Poy Sin General Manager PT. WRP Buana Multicorpora Jalan Jermal, No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

K994426 Re : Glovetex, Examination Gloves, Powdered Non-Trade Name: Sterile (Protein Content Labeling 100 Microgram or Less) Requlatory Class: I Product Code: LYY Dated: April 24, 2000 April 28, 2000 Received:

Dear Mr. Ng Poy Sin:

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, Druq, 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 through 542 of

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Page 2 - Mr. Ng Poy Sin

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 premarket notification" (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 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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# INDICATIONS FOR USE

| 510 (k) Number (if known) : | K994426 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device Name : | Glovetex Latex Examination Glove, Powdered<br>Non-Sterile ( Protein Content Labelling )<br>(100 MICROGRAMS OR LESS) |

Indication For Use :

- 1. The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.
(Division Sign-Off
Concurance of CDRH, Office of Device Evaluation (ODE)
ul Infection Control,

(Division Sign-Orion Infection Control, Division.
and General Hospital De 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counte Use

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