(117 days)
Not Found
No
The device description and intended use clearly define the device as examination gloves, with no mention of AI or ML technology.
No
The device is described as a glove intended to prevent contamination, which is a barrier function, not a therapeutic action.
No
Explanation: The device, Powder Free Nitrile Examination Gloves (Orange), is intended to prevent contamination and is described as an examination glove. Its purpose is protective and not to diagnose any condition or disease.
No
The device is a physical glove, not software. The description clearly states it is a disposable device worn on the hand or finger and meets ASTM standards for physical gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between examiner and patient by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (nitrile), color, and compliance with a standard for examination gloves. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical device, specifically an examination glove, but it falls under the category of a physical barrier device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Product codes
LZA
Device Description
The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
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
examiner
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. 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, with three intertwined lines forming a shape that suggests a human figure or a stylized bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
Comfort Rubber Gloves Industries Sdn. Bhd. Chan Men OA & OMS Manager Lot 821, Jalan Matang Matang, 34750 MY
Re: K171541
Trade/Device Name: Powder Free Nitrile Examination Gloves (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 29, 2017 Received: September 1, 2017
Dear Chan Men:
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 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 (DICE) 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 (DICE) 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.
Sincerelv.
Tara A. Ryan -S
for Tina Kiang, Ph.D. 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
Attachment 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)
Device Name
Powder Free Nitrile Examination Gloves (Orange)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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.
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."
3
510(k) SUMMARY
POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
1.0 Submitter :
| Name | : Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | : Lot 821, Jalan Matang, |
| 34750 Matang, Perak, Malaysia. | |
| Malaysia. | |
| Phone No. | : 605-847 2777 |
| Fax No. | : 605-847 9108 |
| Contact Person | : Chan Yew Men (Mr.) |
Date of Preparation : September 8, 2017
2.0 Name of the Device
Powder Free Nitrile Examination Gloves (Orange)
| Common Name : | Patient Examination Gloves |
|---|---|
| Regulation Name : | Patient Examination Gloves (21 CFR 880.6250 product |
| code LZA) | |
| Device Class : | Class I |
| 510(K) Number : | K171541 |
3.0 Identification of The Legally Marketed Devices That equivalency is claimed:
Predicate
Device Name : Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile
Company : WRP Rubber Products Sdn. Bhd.
510(K) No. : K140418
4.0 Description of the Device:
The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Intended Use of the Device
The Powder Free Nitrile Examination Gloves (Oranqe) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
4
Summary of the Technological Characteristics of the Device: 6.0
The Powder Free Nitrile Examination Gloves (Orange) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1 and Figure 1 on Location of thickness and length measurement.
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| Manufacturer(s) | WRP | |||
| Rubber | ||||
| Products | ||||
| Sdn Bhd | Comfort Rubber | |||
| Gloves | ||||
| Industries Sdn. | ||||
| Bhd | N/A | |||
| 510(k) number | K140418 | K171541 | N/A | |
| Length | ASTM D6319 - | |||
| 10(2015) | Length-Min 230mm | |||
| width - min 95 ± 10 | ||||
| mm | Length-Min | |||
| 240mm | ||||
| width - min 85 | ||||
| mm for medium | ||||
| glove | Same | |||
| Physical Properties | ASTM D6319 - | |||
| 10(2015) | Meets | |||
| Before Aging | ||||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate | ||||
| Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate | ||||
| Elongation | ||||
| Min 400% | Meets | |||
| Before Aging | ||||
| Tensile Strength | ||||
| Min 14 MPa | ||||
| Ultimate | ||||
| Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate | ||||
| Elongation | ||||
| Min 400% | Same | |||
| Thickness - Finger |
- Palm | ASTM D6319 -
10(2015) | Meets
Palm - Min
0.05mm
Finger - Min
0.05mm | Meets
Palm - Min
0.05mm
Finger - Min
0.05mm | Same |
| Powder Content | ASTM D6124 -
06(2011)
(≤ 2 mg/glove) | Meets
≤ 2 mg/glove | Meets
≤ 2 mg/glove | Same |
| Biocompatibility | Primary Skin
Irritation
ISO 10993-10:2010
Biological
evaluation of
medical devices --
Part 10: Tests for
irritation and skin | Under the
conditions of the
study, not an
irritant. | Passes
Under the
conditions of the
study, the
subject device is
non-irritating | Same |
| | sensitization | | | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | substantially
equivalent to
predicate |
| | | Predicate | Current | |
| | Dermal
Sensitization
ISO 10993-10:2010
Biological
evaluation
of
medical devices --
Part 10: Tests for
irritation and skin
sensitization | Under the
conditions of the
study, not a
sensitizer. | Passes
Under the
conditions of the
study, the
subject device is
non-sensitizing | Same |
| Watertight (1000ml) | 21 CFR 800.20
ASTM D5151 | Passes
AQL 2.5 | Passes
AQL 2.5 | Same |
| Intended Use | - | A 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 Powder
Free Nitrile
Examination
Gloves (Orange)
is a disposable
device intended
for medical
purpose that is
worn on the
examiner's hand
or finger to
prevent
contamination
between
examiner and
patient. | Same |
| Material | ASTM D6319 -
10(2015) | Nitrile | Nitrile | Similiar |
| Color | - | Blue | Orange | - |
| Size | Medical Glove
Guidance Manual -
Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small -
75mm±5mm
Small -
85mm±5mm
Medium -
95mm±5mm
Large -
105mm±5mm
Extra Large
-115mm±5mm
Double Extra
Large
120mm
Length-Min
240mm | Same |
| Single Use | Medical Glove
Guidance Manual -
Labeling | Single Use | Single Use | Same |
5
6
7.0 Non-Clinical Performance Data Conclusion:
The subject device and the predicate non-clinical testing results demonstrate that the devices are similar or the same for the following non-clinical testing endpoints: physical properties (same specifications for thickness and length), powder content, biocompatibility, and water tight test.
8.0 Clinical Performance Data Conclusion:
NA
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the Powder Free Nitrile Examination Gloves (Orange) device is substantially equivalent to the predicate device K140418.