EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE

K141590 · Eco Medi Glove Sdn. Bhd. · LZA · Sep 3, 2014 · General Hospital

Device Facts

• Record ID: K141590
• Device Name: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 3, 2014
• 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. It is for over-the-counter use.

Device Story

Disposable, non-sterile, powder-free blue nitrile medical examination glove; worn on examiner's hands or fingers; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical or home settings; intended for over-the-counter use; provides protection during medical examinations.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D6319-10 for dimensions, physical properties (tensile strength, elongation), freedom from pinholes (AQL 2.5), and residual powder. Biocompatibility testing performed per 16 CFR Part 1500 (Primary Skin Irritation) and ISO 10993-10:2010(E) (Dermal Sensitization), confirming the device is not an irritant or sensitizer.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Powder-free, non-sterile, blue, disposable glove. Dimensions and physical properties comply with ASTM D6319-10. Biocompatibility tested per 16 CFR Part 1500 and ISO 10993-10:2010(E).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. 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

• RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K100603)
• RS Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K112928)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

September 3, 2014

Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23826 Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 MALAYSIA

Re: K141590

Trade/Device Name: EMG Blue Nitrile Medical Examination Glove Powder Free (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 08, 2014 Received: August 12, 2014

Dear Mr. Kumar:

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.

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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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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K141590

Device Name

EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)

Indications for Use (Describe)

A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) Summary EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)

#### 1.0 Submitter :

| Company Name | : ECO MEDI GLOVE SDN. BHD |
|-------------------|----------------------------------------------------------------------------------------------------------|
| Company Address : | Lot 23826,Jalan Tembaga Kuning<br>Kamunting Raya Industrial Estate<br>34600,Kamunting Perak<br>Malaysia. |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| Email | : [e-mail] |

#### 2.0 Preparation Date : 22nd August 2014

### 3.0 Name of the Device

Trade Name / Proprietary Name : EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)

Device Name : Nitrile Patient Examination gloves

Device Classification Name : Patient Examination gloves (21 CFR 880.6250)

Device Class : Class I

Product Code : Nitrile-LZA

#### 4.0 Identification of The Legally Marketed Device :

Class I patient Examination gloves,Powder Free,LZA which meets all the

requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K

100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-

Sterile )

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#### 5.0 Description of Device

Blue Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound,Blue colour, powder free and non sterile.

#### 6.0 Intended use of the Device

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. It is for over-the-counter use.

## 7.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion

There is no different technology characteristics compared to the predicate device . Gloves are made from nitrile latex compound, Blue colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-Sterile )

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| Characteristics | Acceptance Criteria | EMG Blue Nitrile<br>Medical Examination<br>Gloves<br>( Powder Free) | RS Blue Nitrile Medical<br>Examination Gloves<br>Powder Free<br>( Non-Sterile ) K 112928 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| Intended use | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. The device is<br>for over-the-counter<br>use.Intended use | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. | A powder free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>counter use. |
| Material use | Not made from Natural Rubber<br>Latex | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Dimensions | Overall Length (mm)<br>= 230mm<br><br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br><br>Thickness at Palm (mm)<br>= 0.05min<br><br>Thickness at Finger Tip (mm)<br>= 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| | Before Ageing | | |
| | Tensile Strength (MPa)<br>= 14min | | |
| | Ultimate Elongation (%)<br>= 500min | | |
| Physical properties | After Aging at 70℃ for<br>168 hrs @ 100ºC for 22 hrs | | Meets ASTM D6319-10 |
| | Tensile Strength (MPa)<br>= 14min | Meets ASTM D6319-10 | |
| | Ultimate Elongation (%)<br>= 400min | | |
| Freedom from pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Biocompatability test-<br>Primary Skin Irritation<br>Test | | Under the conditions of<br>the study, not an irritant<br>and Under conditions of<br>the study , not a<br>sensitizer | Under the conditions of the<br>study, not an irritant and<br>Under conditions of the<br>study , not a sensitizer |
| Dermal Sensitization<br>Assay | | Under the conditions of<br>the study, not an irritant<br>and Under conditions of<br>the study , not a<br>sensitizer | Under the conditions of the<br>study, not an irritant and<br>Under conditions of the<br>study , not a sensitizer |

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EMG Blue Nitrile Medical Examination Gloves Powder Free posting the following technological characteristics

compared to ASTM or Equivalent standards:

| Acceptance Criteria | Standards | Device Performance<br>EMG Blue Nitrile Medical<br>Examination Gloves<br>Powder Free<br>( Non-Sterile ) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------|
| Dimension<br>Overall Length (mm)<br>= 230mm<br><br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br><br>Thickness at Palm (mm)<br>= 0.05min<br>Thickness at Finger Tip (mm)<br>= 0.05min Dimension | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Before Ageing<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 500min<br><br>After Aging at 70°C for<br>168 hrs @ 100°C for 22<br>hrs<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |

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| Freedom from pinhole<br>AQL 2.5<br>Inspection Level G-1 | ASTM D 6319-10 | Specification within ASTM<br>D6319-10 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Residual Powder<br>$≤$ 2.0 mg/pc | ASTM D 6319-10 | Specification within ASTM<br>D6319-10 |
| Biocompatability | Primary Skin Irritation Test<br>Consumer Product Safety<br>Commission, Title 16,<br>Chapter II, Part 1500 | Under the conditions of the<br>study, not an irritant and<br>Under conditions of the<br>study , not a sensitizer |
| | Dermal Sensitization<br>Assay-<br>ISO 10993-10:2010(E) | Under the conditions of the<br>study, not an irritant and<br>Under conditions of the<br>study , not a sensitizer |

## 8.0 Conclusion

The Conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally Marketed device