(60 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML.
No.
The device is an examination glove, which is a barrier to prevent contamination, not a device that provides therapy for a medical condition.
No
Explanation: The device is a patient examination glove used for contamination prevention during medical examinations and handling chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical product, "EMG Blue Nitrile Examination Gloves Powder Free," and details its material, color, and physical properties. There is no mention of software as the primary component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs." This describes a barrier device used externally on the body.
- Device Description: The description reinforces that it's a "patient examination glove made from nitrile latex compound... worn on the examiner's hand or finger."
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This glove does not perform any such analysis or testing of biological specimens.
- Regulatory Classification: The device is classified as "Per 21 CFR 880.6250, class I," which is the classification for patient examination gloves. IVD devices fall under different regulatory classifications (often Class II or III depending on the risk).
The testing for chemotherapy drug permeation is a performance characteristic of the glove as a barrier, not an indication that it is an IVD.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs.
In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs
Product codes
LZA, LZC
Device Description
The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
Summary of Chemotherapy Drug Permeation:
- Carmustine (BCNU)(3.3 mg/ml): 24.0 Minutes
- Cyclophoshamide (20 mg/ml): > 240 Minutes
- Doxorubicin Hydrochloride (2mg/ml): > 240 Minutes
- Etoposide (20mg/ml): > 240 Minutes
- Fluorouracil (50mg/ml): > 240 Minutes
- Methorexate (25mg/ml): > 240 Minutes
- Paclitaxel (6mg/ml): > 240 Minutes
- Thiotepa (10mg/ml): 56.9 Minutes
- Carboplatin (10mg/ml): > 240 Minutes
- Cisplatin (1 mg/ml): > 240 Minutes
- Dacarabazine (1 mg/ml): > 240 Minutes
- Ifosfamide (5 mg/ml): > 240 Minutes
- Mitomycin (0.5mg/ml): > 240 Minutes
- Mitoxantrone (2 mg/ml): > 240 Minutes
- Vincristine Sulfate (1 mg/ml): > 240 Minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile Strength (MPa): 14min (Before Ageing), 14 Min (After Aging at 70 °C for 168 hrs @ 100°C for 22 hrs)
Ultimate Elongation (%): 500min (Before Ageing), 400min (After Aging at 70 °C for 168 hrs @ 100°C for 22 hrs)
Pin-hole Level: AQL 2.5
Residual Powder:
§ 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.
0
Public Health Service
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
July 7, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ECO Medi Glove Sdn. Bhd. Suresh Kumar Official Correspondent Lot 23826. Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, 34600 Malaysia
Re: K171339
Trade/Device Name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 15, 2017 Received: May 19, 2017
Dear Suresh 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.
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
1
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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark S. Fellman -S
for
Lori A. Wiggins, MPT, CLT Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171339
Device Name
EMG Blue Nitrile Examination Glove Powder Free with tested for use with Chemotherapy Drugs
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs.
In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs
Chemotherapy Drugs and Concentration
Minimum Breakthrough Detection Time(Min),ug/cm2/minutes
| 1) Carmustine (BCNU)(3.3 mg/ml) | 24.0 Minutes |
|---|---|
| 2)Cyclophoshamide (20 mg/ml) | > 240 Minutes |
| 3)Doxorubicin Hydrochloride (2mg/ml) | > 240 Minutes |
| 4)Etoposide (20mg/ml) | > 240 Minutes |
| 5)Fluorouracil (50mg/ml) | > 240 Minutes |
| 6)Methorexate (25mg/ml) | > 240 Minutes |
| 7)Paclitaxel (6mg/ml) | > 240 Minutes |
| 8)Thiotepa (10mg/ml) | 56.9 Minutes |
| 9)Carboplatin (10mg/ml) | > 240 Minutes |
| 10)Cisplatin (1 mg/ml) | > 240 Minutes |
| 11)Dacarabazine (1 mg/ml) | > 240 Minutes |
| 12)Ifosfamide (5 mg/ml) | > 240 Minutes |
| 13)Mitomycin (0.5mg/ml) | > 240 Minutes |
| 14)Mitoxantrone (2 mg/ml) | > 240 Minutes |
| 15)Vincristine Sulfate (1 mg/ml) | > 240 Minutes |
The Maximum testing is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BCNU)(3.3 mg/ml) - Minimum breakthrough detection time : 24.0 minutes Thiotepa (10mg/ml) - Minimum breakthrough detection time : 56.9 minutes
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777 FAX +60-5-891 2000
510(K) Summary EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
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 |
| : suresh@ecomediglove.com.my |
- 2.0 Preparation Date : 4th July 2017
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs.
Device Name : Nitrile Patient Examination gloves.
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I.
Product Code : Nitrile-LZA and LZC.
5
(formerly known as Sinetimed Consumables Sdn. Bhd.)
amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777
4.0) Identification of The Legally Marketed Device :
EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs.LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K161187, EMG Blue Nitrile Examination Glove Powder Free with tested for use with Chemotherapy Drugs.
5.0 Device Description
The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) (Minimum) | 230 | 230 | 230 | 230 |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | ||||
| (Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
| Thickness at Finger Tip | ||||
| (mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
6.1 Specification for Nitrile gloves: 6.2 Dimension and Thickness of Gloves
6
ECO Medi 5262-D)
(for
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
| Measurement | Before Ageing | 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 | AQL 2.5 |
| | Inspection Level G-1 | Inspection Level G-1 |
6.1.2 Gloves Physical Properties and Holes
Gloves meet all the specification listed in ASTM D 6319-10
| Characteristics | Acceptance Criteria | EMG Blue Nitrile
Examination Gloves
Powder Free with
tested for use with
chemotherapy drugs.
K171339 | EMG Blue Nitrile
Examination Gloves,
Powder Free with
tested for use with
chemotherapy drugs,
K161187 | Comparison | | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Code | LZA and LZC | LZA and LZC | LZA and LZC | Same | | | | |
| 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.
The device is for over-
the-counter use.
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.
The device is for over-
the-counter 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.
The device is for over-
the-counter use. | Same | | | | |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound | Same | | | | |
| Color | Blue | Blue | Blue | Same | | | | |
| Sterility | Non sterile | Non sterile | Non sterile | Same | | | | |
| Single used | Single used | Single used | Single used | Same | | | | |
| | | | | | | | | |
| Dimensions | Overall Length (mm)
Min 230 mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
Min; 0.05 mm
Thickness at Finger Tip (mm)
Min 0.05 mm | Size : Medium
Palm Width: 98 mm
Length : 247 mm
Finger Thickness : 0.08mm
Palm Thickness : 0.05mm
Meets ASTM D6319-10 | Size : Medium
Palm Width: 99 mm
Length : 247 mm
Finger Thickness : 0.11mm
Palm Thickness : 0.07mm
Meets ASTM D6319-10 | Same | | | | |
| Physical
properties | Before Ageing
Tensile Strength (MPa)
= Min 14 Mpa
Ultimate Elongation (%)
= Min 500 %
After Aging at 70°C for
168 hrs @ 100°C for
22 hrs
Tensile Strength (MPa)
= Min 14 Mpa
Ultimate Elongation (%)
= Min 400 % | Tensile strength (Mpa) :
Before aging : 25.45Mpa
After Accelerated aging:
26.33Mpa
Ultimate Elongation(%):
Before aging:600%
After aging : 550%
Meets ASTM D6319-10 | Tensile strength (Mpa) :
Before aging : 25.45Mpa
After Accelerated aging:
26.33Mpa
Ultimate Elongation(%):
Before aging:600%
After aging : 550%
| Same | | | | |
| | Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | AQL 2.5
Meets ASTM D5151-06 | AQL 2.5
Meets ASTM D5151-06 | | | | |
| | Residual
Powder | 240
minutes | 9) Thiotepa (10mg/ml or
10,000ppm),
Breakthrough time: 67.8
minutes. | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| 8) Paclitaxel (6mg/ml or
6,000ppm),
Minimum Breakthrough
detection time:
240minutes | | |
| 9) Thiotepa (10mg/ml or
10,000ppm),
Minimum Breakthrough
detection time:
56.9 minutes | | |
| 10) Ifosfamide
(50mg/ml)
Minimum Breakthrough
detection time: >240
minutes | | |
| 11) Mitoxantrone
(2mg/ml) ,
Minimum Breakthrough
detection time: >240
minutes | | |
| 12) Vincristine Sulfate
(1mg/ml) ,
Minimum Breakthrough
detection time: >240
minutes | | |
| 13) Carboplatin
(10.0mg/ml), Minimum
Breakthrough detection
time: >240 minutes | | |
| | 14) Dacarbazine (DTIC)
(10.0mg/ml) Minimum
Breakthrough detection
time: >240 minutes | |
| | 15) Mitomicin C
(0.5mg/ml) Minimum
Breakthrough detection
time: >240 minutes | |
10
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
7.0 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 and for use with chemotherapy drugs .
In addition these gloves were tested for use with Chemotherapy drugs in accordance With ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes,µg/cm²/minute |
|---|---|
| 1)Carmustine (BCNU) (3.3mg/ml) | 24 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (10mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 56.9 minutes |
| 10) Cisplatin (1.0mg/ml) | > 240 minutes |
11
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA.
| 11) Dacarbazine (DTIC) (10.0mg/ml) | > 240 minutes |
|---|---|
| 12) Ifosfamide (50.0mg/ml) | > 240 minutes |
| 13) Mitomycin C (0.5mg/ml) | > 240 minutes |
| 14) Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 15) Vincristine Sulfate (1.0mg/ml) | > 240 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time,
Carmustine (BCNU) (3.3mg/ml) - Minimum Breakthrough detection time 24 Minutes
Thiotepa (10mg/ml) - Minimum Breakthrough detection time 56.9 minutes.
8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion
There are no differences in technological characteristics of the subject device compare with the predicate device.
The gloves are made from nitrile latex compound, Blue color, Powder free and nonsterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to Chemotherapy drugs.
9.0 Conclusion
Based on intended uses, technological characteristics and non - clinical performance Data, the EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs is as safe, as effective, and performs as well as the legally marketed predicate device, K161187.