EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

• K Number: K152937
• Device Name: EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
• Manufacturer: ECO MEDI GLOVE SDN. BHD.
• Date Cleared: 2016-06-23 ( 262 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner

Device Description

Blue Nitrile Examination gloves powder free with Peppermint Scented , 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 color, Powder free and non sterile.

Predicate Devices

K070097

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard examination glove and makes no mention of AI or ML technology.

Therapeutic

No
This device, a patient examination glove, is intended to prevent contamination between patients and examiners, not to treat or cure a disease or condition.

Diagnostic

No
This device is a patient examination glove, which is a barrier to prevent contamination, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is a "powder free patient examination glove...worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
• Device Description: The description focuses on the physical characteristics of the glove (material, color, scent, sterility) and its compliance with standards for examination gloves. It does not mention any components or functions related to analyzing biological samples.
• Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical properties and biocompatibility of the glove, which are relevant to its use as a barrier device.

Therefore, this device falls under the category of a medical device used for protection and examination, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

Blue Nitrile Examination gloves powder free with Peppermint Scented , 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 color, Powder free and non sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hands or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was completed in accordance with ASTM D6319-10 , ASTM D5151-06, and ASTM D6124-06. The glove meet standards requirement referenced in section 6.0 above. Biocompatibility testing per ISO 10993-10:2010 indicates that the subject gloves are non-sensitizing and non-irritating under the conditions tested

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Measurement	Before Aging	After Aging at 70°C for 168 hrs @ 100°C for 22 hrs
Tensile Strength (MPa)	14min	14 Min
Ultimate Elongation (%)	500min	400min
Pin-hole Level	AQL 2.5 Inspection Level G-1	AQL 2.5 Inspection Level G-1
Residual Powder	≤ 2.0 mg/pc	Not Found
Biological Evaluation on Medical Device -Primary Skin Irritation Test .	Not Found	The test article is a non-irritant per ISO 10993-10.
Biological Evaluation on Medical Device- Dermal Sensitization Assay .	Not Found	The test article is a non-sensitizer per ISO 10993-10.

Predicate Device(s)

K070097

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

June 23, 2016

Eco Medi Glove Sdn. Bhd. Mr. Suresh Kumar Official Correspondent Lot 23826. Jalan Tembaga Kuning. Kamunting Raya Industrial Estate Taiping Perak, 34600 MALAYSIA

Re: K152937

Trade/Device Name: EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 2, 2016 Received: May 13, 2016

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. Isting 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.

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

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152937

Device Name

EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint scented

Indications for Use (Describe)

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger 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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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ECO Medi Glove Sdn

ables merly known as Sinetimed

t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. L [phone] FAX [phone]

510(K) Summary EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented.

1.0 Submitter :

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

• 2.0 Preparation Date : 2nd June 2016 .

3.0 Name of the Device

Trade Name / Proprietary Name : EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

Device Name : Nitrile Patient Examination gloves .

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

Device Class : Class I .

Product Code : LZA .

4

ECO Medi Glove Sdn. Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL [phone] FAX [phone]

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 K070097.Powder Free Nitrile Examination Glove, Peppermint Scented , blue Color

5.0 Description of Device :

Blue Nitrile Examination gloves powder free with Peppermint Scented , 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 color, Powder free and non sterile.

6.0 Executive summary :

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is a disposable glove made of nitrile latex compound Blue color powder free. This Blue Nitrile Examination Gloves Powder Free with Peppermint Scented 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 .

Dimension	Size S	Size M	Size L	Size XL
Overall Length (mm)	230min	230min	230min	230min
Width (± 5mm)	85	95	105	115
Thickness at Palm (mm)	0.05min	0.05min	0.05min	0.05min
Thickness at Finger Tip (mm)	0.05min	0.05min	0.05min	0.05min

6.1.1 Specification for Nitrile gloves: 6.1.1.1 Dimension and Thickness of Gloves .

Section 2A-2

5

BCO Medi Glo . Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. [phone]

| Measurement | Before Aging | After Aging at 70°C for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |

6.3.2.2 Gloves Physical Properties and Holes

Gloves meet all the specification listed in ASTM D 6319-10.

7.0 Intended use of the Device :

A Powder-free patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner .

8.0 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 color, powder free and non sterile. It is equivalent to K070097,Powder Free Nitrile Examination Glove, Peppermint Scented, blue Color

| Characteristics | Acceptance Criteria | EMG Powder Free
Nitrile Examination
Glove (Blue) with
Peppermint Scented | Powder Free Nitrile
Examination Glove,
Peppermint Scented ,
blue Color
510K#:070097 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| 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. | 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. | 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. |

6

ECO Medi Glove Sdn. Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. FAX [phone] TEL [phone]

| | The device is for over-the-
counter use. | The device is for over-
the-counter use. | The device is for over-the-
counter use. | |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Material use | Not made from Natural Rubber
Latex. | Nitrile latex compound. | Nitrile latex compound. | |
| Colour | Peppermint Scented , blue
Color | Peppermint Scented ,
blue Color | Peppermint Scented , blue
Color | |
| Sterility | Non sterile | Non sterile | Non sterile | |
| Dimensions | Overall Length (mm)
= Min 230mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
= Min 0.05min
Thickness at Finger Tip (mm)
= Min 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | |
| | | | | |
| Physical properties | Before Aging
Tensile Strength
(MPa)
= Min 14min

Ultimate
Elongation (%)
= Min 500min

After Aging at
70°C for
168 hrs @
100°C for 22
hrs

Tensile Strength
(MPa)
= Min 14min

Ultimate
Elongation (%)
= Min 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | |
| | Freedom from pinholes | AQL 2.5
Inspection Level
G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| | Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| | Biological Evaluation on Medical
Device -Primary Skin Irritation
Test . | The test article
is a non-irritant
per ISO 10993-
10. | Under the conditions of
this study, the test article
was a non-irritant. | Under the conditions of this
study, the test article was a non-
irritant. |
| Biological Evaluation on Medical
Device-
Dermal Sensitization Assay . | The test article
is a non-
sensitizer per
ISO 10993-10. | Under the conditions of
this study, the test article
was a non-sensitizer. | Under the conditions of this
study, the test article was a non-
sensitizer. | |

Section 2A-4

7

ECO Medi Glove Sdn. Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL [phone] FAX [phone]

Section 2A-5

8

ECO Medi Glove Sdn. Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.

Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. TEL [phone] FAX [phone]

9.0) Substantial Equivalent Based on Assessment of Non-Clinical Performance data

Performance testing was completed in accordance with ASTM D6319-10 , ASTM D5151-06, and ASTM D6124-06. The glove meet standards requirement referenced in section 6.0 above. Biocompatibility testing per ISO 10993-10:2010 indicates that the subject gloves are non-sensitizing and non-irritating under the conditions tested

9.0 Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented is as safe, as effective, and performs as well as the legally marketed predicate device K070097 Powder Free Nitrile Examination Glove, Peppermint Scented, Blue Color