BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE

K090464 · Pt Mahakarya Inti Buana · LZA · Apr 23, 2009 · General Hospital

Device Facts

• Record ID: K090464
• Device Name: BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
• Applicant: Pt Mahakarya Inti Buana
• Product Code: LZA · General Hospital
• Decision Date: Apr 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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.

Device Story

Disposable, non-sterile, powder-free black nitrile examination glove; worn by healthcare examiners to provide a protective barrier against contamination between patient and examiner. Device functions as a physical barrier; manufactured from nitrile latex. Used in clinical or medical settings. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing including physical dimensions, physical properties (tensile strength, ultimate elongation), freedom from pinholes, moisture content, powder residue, and biocompatibility (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Nitrile latex. Form factor: Powder-free, non-sterile examination glove. Standards: ASTM D 6319-00a(2005). Physical properties: Tensile strength > 14 MPa (unaged/aged), Ultimate elongation > 500% (unaged) and > 400% (aged). Biocompatibility: Passed primary skin irritation and dermal sensitization tests.

Indications for Use

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

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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K0904664

Image /page/0/Picture/1 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or old English font. The letters are large and bold, with intricate details and serifs characteristic of this type of font. The overall impression is one of formality and tradition.

.. - .

## PT. MAHAKARYA INTI BUANA

Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa – 20362
SUMUT – INDONESIA

Tel [phone], 51, 52, 53
Fax [phone]

## Date : February 10, 2009

## 510 (K) SUMMARY

APR 2 3 2009

| 1.0 | Submitter: | | |
|-----|------------------------------------------------|------------------------------------------------|----------|
| | Name | PT MAHAKARYA INTI BUANA | |
| | Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 | |
| | | Tanjung Morawa – 20362 | |
| | | SUMUT – INDONESIA | |
| | Phone No. | [phone], 51 | |
| | Fax No. | [phone] | |
| | FDA Registration No : | 3004049816 | |
| 2.0 | Contact Person: | | |
| | Name | (Mr) Azman Ismail | |
| | Phone | +62-61-30007150,51 | |
| | Fax No. | [phone] | |
| | E-mail | [e-mail] | |
| 3.0 | Name of the device: | | |
| | Trade Name | 1) Senstouch and | |
| | | 2) Multiple or Customers' Trade Name | |
| | Device Name | Black Nitrile Examination Gloves, Powder Free, | |
| | | Non Sterile | |
| | Common Name | Patient Examination Gloves | |
| | Classification Name | Nitrile Examination Gloves | |
| 4.0 | Identification of The Legally Marketed Device: | | |
| | Polymer | Nitrile Latex | |
| | Device Class | Class I | |
| | Substantial Equivalent | | |
| | Device Description | Patient Examination Gloves, 21 CFR 880.6250 | |
| | Product Code | Nitrile - 80LZA | |
| | Standard | ASTM D 6319-00a (2005) | |
| 5.0 | Performance Testing Standard: | | |
| | Water Leak Test | G-I, AQL 1.5 | |
| | Physical Dimension | S-2, AQL 4.0 | |
| | Physical Properties | S-2, AQL 2.5, Single Sampling | |
| | Residual Powder | N = 5 | |
| | Moisture Content | N=8 | |
| | Visual Inspection | Critical Defects | AQL 0.65 |
| | | Major Defects | AQL 2.5 |
| | | Minor Defects | AQL 4.0 |
| | | | |
| | | | |

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Image /page/1/Picture/0 description: The image shows a stylized, gothic-style monogram consisting of the letters 'M' and 'B'. The letters are rendered in a bold, black color with intricate details and sharp edges, giving them a medieval or old-world appearance. The 'M' and 'B' are intertwined, creating a unified design that could be used as a logo or emblem. The overall impression is one of classic elegance and historical significance.

### PT. MAHAKARYA INTI BUANA

Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa -- 20362 SUMUT - INDONESIA

Tel [phone], 51, 52, 53 Fax [phone]

#### 6.0 Intended Use of The Device

Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

### 7.0 Summary of The Technological Characteristics of The Device (Performance and Conformance Test Data):

Technological characteristics of Black Nitrile Examination Gloves, Powder Free, Non Sterile are summarized as below:-

| | REFERENCE | DEVICE | STANDARD |
|-----------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| REQUIREMENT | STANDARDS | PERFORMANCE | SPECIFICATION |
| Physical Dimension | D 6319-00aE3 | Length = 240.9 mm<br>Width = 97.7 mm<br>Thickness:<br>- Finger = 0.148 mm<br>- Palm = 0.109 mm<br>- Cuff = 0.092 mm | Length $\geq$ 230 mm<br>Width = 95 + 10<br>Thickness $\geq$ 0.05 |
| Physical Properties | D 6319-00aE3 | Unaged:<br>TS = 18.8 MPa<br>UE = 679.4 %<br>Aged:<br>TS = 21.3 MPa<br>UE = 767.4 % | Unaged:<br>TS = 14 MPa<br>UE = 500 %<br>Aged:<br>TS = 14 MPa<br>UE = 400 % |
| Freedom from Pinholes | D 6319-00aE3<br>FDA 21 CFR<br>800.20 | | Acc / Rej = 3 / 4 |
| Moisture Content | In-house | 0.46% | 0.8% |
| Powder Residue | D 6319-00aE3<br>D6124 - 01 | 0.96 mg/glove | < 2.0 mg/glove |
| Biocompatibility | Primary Skin<br>Irritation in<br>Rabbits<br>Dermal<br>Sensitization | Pass<br>(Negative)<br>Pass<br>(Negative) | Pass<br>Pass |

Table 7.0 Performance and Conformance Data of Black Nitrile Examination Glove

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Image /page/2/Picture/0 description: The image shows a stylized monogram of the letters 'M' and 'B' in a gothic or blackletter style. The letters are rendered in black against a white background, with a textured or slightly distressed appearance. The 'M' and 'B' are intertwined or overlapping, creating a unified design.

### PT. MAHAKARYA INTI BUANA

Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa - 20362 SUMUT - INDONESIA

Tel [phone],51,52,53 Fax [phone]

### Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

Based on the above data and information, the device is substantially equivalent to its predicate device approved for distribution in the United States. Part 4 of this submission discusses further on substantial equivalent comparison

#### Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 Clinical data is not required for gloves for this submission.

#### 10.0 Conclusion

It can be concluded that the Black Nitrile Powder Free Nitrile Black Examination Gloves, Non Sterile perform according to the gloves performance standards referenced in Section (5) and (7) above and hence meet ASTM standards and FDA requirements.

Conclusively, we therefore claim that this device is substantially equivalent to its predicate device approved by FDA and is safe and effective for its intended for purposes.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 2 3 2009

Mr. Azman Ismail Quality Assurance Manager PT. MAHAKARYA INTI BUANA Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Number 18 Tanjung Morawa - 20362 SUMUT - INDONESIA

Re: K090464

Trade/Device Name: Black Nitrile Examination Gloves, Powderfree, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 13, 2009 Received: April 15, 2009

Dear Mr. Ismail:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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Page 2- Mr. Ismail

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D, on steam for

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

: :

510(k) Number (if known): K 090464

Device Name: Black Nitrile Examination Gloves, Powderfree, Non-Sterile

Indications for use:

A powder-free 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.

Prescription Use

AND/OR

Over-The-Counter Use X

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.4CJ. Ja. bem

(Division Sign-Off) (Division Sign-Off) Division of Anton, Dental Devices

510(k) Number: K090464

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