DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS

K110979 · Advanced Medical Products Sdn Bhd · LZA · Oct 20, 2011 · General Hospital

Device Facts

• Record ID: K110979
• Device Name: DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
• Applicant: Advanced Medical Products Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

Device Story

Disposable nitrile patient examination glove; worn on hand or forefinger by healthcare providers or other users. Acts as physical barrier to prevent cross-contamination between examiner and patient bodily fluids, waste, or environment. Non-sterile; powder-free. Manufactured to meet ASTM standards for physical properties, dimensions, and thickness. Used in clinical or general medical settings. Provides protection to both patient and examiner by reducing exposure to contaminants.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing (ASTM D6319-10), powder residue testing (ASTM D6124-06), watertight integrity (ASTM D5151-06), and biocompatibility (ISO 10993-10:2002(E) and CPSC 16 CFR 1500).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, non-sterile, powder-free examination glove. Standards: ASTM D6319-10 (dimensions, physical properties, thickness), ASTM D6124-06 (powder-free, ≤ 2 mg/glove), ASTM D5151-06 (watertight). Biocompatibility: Passes primary skin irritation and dermal sensitization testing.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between the examiner and patient bodily fluids, waste, or the environment. Suitable for over-the-counter use.

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.

Predicate Devices

• Dermagrip Powder Free Blue Nitrile Examination Gloves (K022904)

Submission Summary (Full Text)

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K 11:09:79

## OCT 2 0 2011

510(K) summary Page 1 of 2

## 510(k) SUMMARY

### 1.0 Submitter:

| Name: | Mr Zahari Darus |
|------------|------------------------------------------------------------------------------------------------------------------------------|
| Address: | Advance Medical Products Sdn Bhd<br>Lot 8961 & 8964, Batu 19 Jalan Beruas, 32400 Ayer Tawar<br>Perak Darul Ridzuan, MALAYSIA |
| Phone No.: | [phone] / [phone] |
| Fax No.: | [phone] |

March 2011 (revised 12 September 2011) Date of Summary Prepared:

### 2.0 Name of the device:

DERMAGRIP ULTRA Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile (and various brandnames)

Common Name: Exam Gloves

Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)

### 3.0 Identification of The Legally Marketed Devices:

Dermagrip Powder Free Blue Nitrile Examination Gloves 510(k) #: K022904 MDL: D36500 Regulatory Class I Product code: LZA

#### 4.0 Description of The Device:

Powder Free Nitrile Examination Gloves, Blue meet all the requirements of ASTM standard D6319-00a, D6124-06 and FDA 21 CFR 880.6250.

#### 5.0 Intended Use of the Device:

The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

### 6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile Examination Gloves are summarized with the following technological characteristics compared to ASTM 6319-00a or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE (Both<br>Predicate and Current) |
|---------------------|---------------|----------------------------------------------------|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness | ASTM D6319-10 | Meets |
| Powder Free | ASTM D6124-06 | Meets<br>$≤ 2 mg/glove$ |

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K 110979

# 510(k) SUMMARY

| Biocompatability | | Passes |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Primary Skin Irritation -<br>Consumer product safety<br>Commission, Title 16,<br>Chapter II, Part 1500:41 &<br>1500:3 (c)(4) | (Not a primary skin irritant) |
| | Dermal Sensitization -Closed<br>patch Test ISO 10993-<br>10:2002(E) | Passes<br>(Not a contact sensitizer) |
| Watertight (1000ml) | ASTM D5151-06 | Passes |

*Details and discussions of tests can be found in performance section

### 7.0 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 equivalence is the same as mentioned immediately above (ASTM Requirements).

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

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

### 9.0 Conclusion

Powder Free Nitrile Examination Gloves, Blue will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing snakes or streams.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Mr. Zahari Darus Operations Manager Advance Medical Products SDN BHD Lot 8961 & 8964. Batu 19 Jalan Beruas, 32400 Ayer Tawar Perak Darul Ridzuan, MALAYSIA

Re: K110979

Trade/Device Name: DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves, Non-sterile (and various brandnames) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 19, 2011 Received: September 22, 2011

Dear Mr. Darus:

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

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.

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### Page 2 - Mr. Darus

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 (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 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 yours, a

Anthony V. a. Auten

Anthony D. Watson, B.S., M.S., M.B.A. 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): K110979

Applicant Name: Advance Medical Products Sdn Bhd

Device Name:

DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves, Non-sterile (and various brandnames)

Indications for Use:

The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

Prescription Use No (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Edith B. Clarence-Will

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

510(k) Number: K110979

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