(85 days)
Not Found
No
The device description and intended use are for a standard examination glove, with no mention of AI or ML capabilities.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, described as being worn on the hand or finger to prevent contamination. Its intended use does not involve diagnosing any medical condition.
No
The device description clearly states it is a physical patient examination glove, which is a hardware device. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner 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 and manufacturing process of a glove, not on any reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is clearly a medical device (specifically, a patient examination glove), but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2017
Careglove Global Sdn Bhd Lim Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, 70450 My
Re: K172015
Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue (colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: Julv 3, 2017 Received: July 3, 2017
Dear Lim Shyan:
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
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, BLUE (COLORED)
Indications for Use (Describe)
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.
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."
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Image /page/3/Picture/0 description: The image shows the logo for "CARE GLOVE". The word "CARE" is written in large, bold, blue letters. Below "CARE" is the word "GLOVE" in a light green color with a blue circle in the middle of the word with a hand in the center. Below the word "GLOVE" is the text "CAREPLUS-DESCARPACK" in blue.
AREGLOVE GLOBAL
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
K172015 510(K) SUMMARY
CAREGLOVE GLOBAL SDN BHD Applicant:
- Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377
Contact Person:Lim Kwee Shyan
- 31st August, 2017 Summary Preparation Date:
Device Information
| Trade Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) |
|---|---|
| Common Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification Name: | Patient Examination Gloves |
| Regulatory Class: | |
| Product Code: | LZA |
| Regulation: | 21 CFR 880.6250 |
| Predicate Device |
| Device Name: | CAREPLUS POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) |
|---|---|
| Product Code: | LZA |
| Classification Name: | Patient Examination Gloves |
| 510K Number: | K142862 |
| Regulatory Class: | I |
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.
Indications for 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.
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Image /page/4/Picture/0 description: The image contains a logo with the words "CARE GLOVE" stacked on top of each other. The word "CARE" is in blue, and the word "GLOVE" is in light green. There is a blue circle with a light green hand in the middle of the word "GLOVE". Below the words "CARE GLOVE" is the word "CAREPLUS-DESCARPACK" in blue.
CAREGLOVE GLOBAL SDI
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
Summary of the Technological Characteristic
The Powder Free Nitrile Examination Gloves – Blue are summarized with the following technological characteristic compare to ASTM D6310 or equivalent standards.
| Characteristic | Subject Device | Predicate Device | Comparison
Analysis |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Powder Free Nitrile
Examination Gloves, Blue
(Colored) | Careplus Powder Free Nitrile
Examination Glove, Blue
(Colored) | Different |
| 510(k) Reference | K172015 | K142862 | N/A |
| Product Code | LZA | LZA | Same |
| Regulatory Class | I | I | Same |
| Intended Use | Intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between
patient and examiner | Intended for medical purposes
that is worn on the examiner's
hand to prevent contamination
between patient and examiner | Same |
| Design | Powder Free, Non-Sterile,
Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile,
Ambidextrous, Beaded Cuff | Same |
| Indications for
Use | A patient examination glove
is a disposable device
intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between
patient and examiner | A patient examination glove is
a disposable device intended
for medical purposes that is
worn on the examiner's hand
to prevent contamination
between patient and examiner | Same |
| Construction | Ambidextrous, Polymer
Coated or Chlorinated,
Powder Free Nitrile | Ambidextrous, Polymer
Coated or Chlorinated, Powder
Free Nitrile | Same |
| Color Description | Blue | Blue | Same |
| Material | Nitrile | Nitrile | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same |
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Image /page/5/Picture/0 description: The image is a logo for a company called "CARE GLOVE." The word "CARE" is written in large, bold, blue letters on top. Below it, the word "GLOVE" is written in a lighter green color. There is a blue circle with a light green hand in the middle of the word "GLOVE." Underneath the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in smaller, blue letters.
CAREGLOVE GLOBAL SDN BHD
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
| Dimension | |||
|---|---|---|---|
| Length (size: XSmall), mm | |||
| Length (size: Small), mm | |||
| Length (size: Medium), mm | |||
| Length (size: Large), mm | |||
| Length (size: XLarge), mm | Meet 220mm min | ||
| Meet 220mm min | |||
| Meet 230mm min | |||
| Meet 230mm min | |||
| Meet 230mm min | Meet 230mm min | ||
| Meet 220mm min | |||
| Meet 230mm min | |||
| Meet 230mm min | |||
| Meet 230mm min | Same | ||
| Thickness (palm), mm | |||
| Thickness (finger), mm | Meet 0.05mm min | ||
| Meet 0.05mm min | Meet 0.05mm min | ||
| Meet 0.05mm min | |||
| Width (size: XSmall), mm | |||
| Width (size: Small), mm | |||
| Width (size: Medium), mm | |||
| Width (size: Large), mm | |||
| Width (size: XLarge), mm | Meet 70 ± 10 mm | ||
| Meet 80 ± 10 mm | |||
| Meet 95 ± 10 mm | |||
| Meet 110 ± 10 mm | |||
| Meet 120 ± 10 mm | Meet 70 ± 10 mm | ||
| Meet 80 ± 10 mm | |||
| Meet 95 ± 10 mm | |||
| Meet 111 ± 10 mm | |||
| Meet 120 ± 10 mm | |||
| Physical Properties | |||
| (Before Ageing) | |||
| i) Tensile Strength (MPa) | |||
| ii) Ultimate Elongation (%) | Meet 14MPa min. | ||
| Meet 500% min | Meet 14MPa min. | ||
| Meet 500% min | Same | ||
| (After Aging) | |||
| i) Tensile Strength (MPa) | |||
| ii) Ultimate Elongation (%) | Meets 14MPa min | ||
| Meet 400% min. | Meets 14MPa min | ||
| Meet 400% min. | |||
| Water Leak Test, | |||
| 1000 ml | |||
| Before Aging, AQL | |||
| After Aging, AQL | Meet AQL 1.5 | ||
| Meet AQL 2.5 | Meet AQL 1.5 | ||
| Meet AQL 2.5 | Same | ||
| Residual Powder Content | |||
| Residual Powder Content, | |||
| mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Same |
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Image /page/6/Picture/0 description: The image shows a logo for a company called "CARE GLOVE". The word "CARE" is in blue, and the word "GLOVE" is in light green. There is a blue circle with a light green hand in the middle of the word "GLOVE". The words "CAREPLUS-DESCARPACK" are in blue at the bottom of the logo.
CAREGLOVE GLOBAL SDN BHD
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
| Biocompatibility Test | |||
|---|---|---|---|
| i) Primary Skin Irritation Test | Passes | ||
| i) Primary Skin Irritation Test. | |||
| Conclusion: Under the conditions of this study the test material did not cause an irritant response | Passes | ||
| i)Primary Skin Irritation Test. | |||
| Conclusion: Under the conditions of this study the test material did not cause an irritant response. | Same | ||
| ii)Skin Sensitization Test | ii)Dermal Sensitization Test. | ||
| Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect | ii)Dermal Sensitization Test. | ||
| Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect |
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Image /page/7/Picture/0 description: The image shows the logo for "CARE GLOVE". The word "CARE" is in large, bold, blue letters on top. Below it, the word "GLOVE" is in a light green color. The "O" in "GLOVE" is replaced by a blue circle with a light green handprint inside. Underneath the word "GLOVE" is the text "CAREPLUS-DESCARPACK" in small, bold, blue letters.
CAREGLOVE GLOBAL SI
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
Summary of Clinical Testing
Not applicable
Substantial Equivalence Conclusions.
The subject device is a safe, as effective, and performs as well as or better than the legally marketed predicate device, K142862 (Careplus Powder Free Nitrile Examination Gloves, Blue (Colored)).