SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)

K111300 · Pt Mahakarya Inti Buana · LZA · Aug 12, 2011 · General Hospital

Device Facts

• Record ID: K111300
• Device Name: SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
• Applicant: Pt Mahakarya Inti Buana
• Product Code: LZA · General Hospital
• Decision Date: Aug 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn on examiner's hands; provides barrier protection to prevent cross-contamination between patient and examiner. Manufactured from synthetic nitrile polymer; non-sterile; powder-free. Used in clinical or medical settings. Protects both patient and examiner during examinations.

Clinical Evidence

No clinical data. Bench testing only, including water leak tests, physical property testing (tensile strength, elongation), residual powder, moisture content, and biocompatibility (primary skin irritation and dermal sensitization in rabbits).

Technological Characteristics

Material: Nitrile latex. Form: Powder-free, non-sterile examination glove. Standards: ASTM D6319-00a(2005). Dimensions: Length ≥ 230 mm, Width 95 ± 10 mm, Thickness ≥ 0.05 mm. Biocompatibility: Tested per 16 CFR Part 1500 and ASTM F720-86.

Indications for Use

Indicated for use by healthcare examiners as a disposable, non-sterile, powder-free nitrile barrier glove 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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K111300

AUG 1 2 2011

Image /page/0/Picture/2 description: The image shows a stylized logo with the letters 'MB' in a bold, gothic-style font. The letters are interconnected and have a textured appearance, giving them a three-dimensional effect. A horizontal line runs through the middle of the letters, adding a graphic element to the design. The overall impression is one of a strong, established brand or organization.

## PT. MAHAKARYA INTI BUANA

Jl .Desa Dalu X-A, Dalu 10
Deli Serdang – T. Morawa
Sumatera Utara – 20362
Indonesia

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

## Date : May 3, 2011

## 510 (K) SUMMARY

| 1.0 | Submitter: | | |
|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Name | : | PT MAHAKARYA INTI BUANA |
| | Address | : | Jl. Desa Dalu X-A, Dalu 10<br>Deli Serdang - T. Morawa<br>Sumatera Utara - 20362 |
| | Phone No. | : | [phone], 51 |
| | Fax No. | : | [phone] |
| | FDA Registration No | : | 3005813621 |
| 2.0 | Contact Person: | | |
| | Name | : | (Ms) Lina Ng |
| | Phone | : | +62-61-30007150,51 |
| | Fax No. | : | [phone] |
| | E-mail | : | [e-mail] |
| 3.0 | Name or The Device: | | |
| | Trade Name | : | 1) Senstouch and<br>2) Multiple or Customers' Trade Name |
| | Device Name | : | Nitrile Examination Gloves, Powder Free, Non Sterile<br>(Green, Orange, Violet and White) |
| | 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-1, AQL 1.5 |
| | Physical Properties | : | 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 Defect AQL 0.65<br>Major Defect AQL 2.5<br>Minor Defect AQL 4.0 |
| | REFERENCE | DEVICE | STANDARD |
| REQUIREMENT | STANDARDS | PERFORMANCE | SPECIFICATION |
| Physical Dimension | D 6319-00aE3 | Length = 246.77 mm<br>Width = 94.46 mm<br>Thickness:<br>- Finger = 0.150 mm<br>- Palm = 0.095 mm<br>- Cuff = 0.082 mm | Length ≥ 230 mm<br>Width = 95 ± 10<br>Thickness ≥ 0.05 |
| Physical Properties | D 6319-00aE3 | Unaged:<br>TS = 15.9 MPa<br>UE = 583.4%<br>Aged:<br>TS = 22.3 MPa<br>UE = 569.2 % | 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 | 0 piece found | Acc / Rej = 3 / 4 |
| Moisture Content | In-house | 0.67% | 0.8% |
| Powder Residue | D 6319-00aE3<br>D6124 - 01 | 0.84 mg/glove | < 2.0 mg/glove |
| Biocompatibility<br>Accordance with "Consumer<br>Product Safety Commission,<br>Title 16, Chapter II, Part<br>1500 and ASTM F720-86 | Primary Skin<br>Irritation in<br>Rabbits<br><br>Dermal<br>Sensitization | Pass<br>(Negative)<br><br>Pass<br>(Negative) | Pass<br><br>Pass |

. .

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# K111300

## PT. MAHAKARYA INTI BUANA

J1 .Desa Dalu X-A, Dalu 10 Deli Serdang - T. Morawa Sumatera Utara - 20362 Indonesia_

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

### 6.0 Intended Use of The Device

Powder Free Green, Orange, Violet and White 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 White Nitrile Examination Gloves, Powder Free, Non Sterile are summarized as below :-

Table 7.0 Performance and Conformance Data of White Nitrile Examination Glove

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K 111300

## PT. MAHAKARYA INTI BUANA

Image /page/2/Picture/2 description: The image shows a stylized logo with the letters 'MB' in a bold, gothic-style font. A horizontal line runs through the middle of the letters, adding a graphic element to the design. The logo is rendered in black against a white background, creating a high-contrast image.

Jl .Desa Dalu X-A, Dalu 10 Deli Serdang - T. Morawa Sumatera Utara – 20362 Indonesia ____________________________________________________________________________________________________________________________________________________________________

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

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

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

### 10.0 Conclusion

It can be concluded that the Green, Orange, Violet and White Nitrile 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 19903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pt. Mahakarya Inti Buana Ms. Lina Ng OSP Manager Dalu 10, Deli Serdang T. Morawa Sumatera Utara Indonesia 20362

AUG 12 2011

Re: Ki11300

Trade/Device Name: Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange. Violet and White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 3, 2011 Received: August 3, 2011

Dear Ms. Ng:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

ff 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 vour 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.

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Page 2 - Ms. Ng

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 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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Cintron D. Martin

Anthony D. Watson. B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devic Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Device Name:

## Indications For use:

# KII1300

GREEN, ORANGE, VIOLET AND WHITE NITRILE EXAMINATION GLOVES POWDER FREE, NON-STERILE

Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clausing-Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __KIJI 300