(322 days)
Not Found
No
The device is a simple examination glove and the description focuses on material properties and manufacturing processes, with no mention of AI/ML or related concepts.
No
The device prevents contamination but does not directly treat a condition or restore a function.
No
Explanation: This device is a patient examination glove, described as a barrier to prevent contamination between a patient and examiner. It is not used for diagnosing medical conditions.
No
The device is a physical patient examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used 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 and manufacturing process of a glove.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies described relate to the physical properties of the glove (ASTM standards) and biocompatibility (skin irritation and sensitization), which are typical for medical devices that come into contact with the body, but not for IVDs.
IVDs are devices used to perform tests on specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This glove does not perform such tests.
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
LYY
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free 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)
Non-clinical laboratory and animal based test indicate that the powder free latex examination glove meets all the performance and biocompatibility requirements.
Testing performed as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20. The subject device meet all the ASTM D3578-05 requirements. Primary skin irritation testing in the rabbit and Closed patch sensitization testing in the guinea pig were conducted in accordance with ISO 10993-10 indicate no irritation or sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
Careglove Global SDN BHD Lim Kwee Shyan Managing Director Lot 17479, Lrg Senawang 3/2 Off Jln Senawang 3 Senawang In Seremban, Negeri Sembilan, 70450 MY
Re: K161833
Trade/Device Name: Latex Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 25, 2017 Received: April 28, 2017
Dear Lim Kwee Shyan:
This letter corrects our substantially equivalent letter of May 23, 2017.
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. Iisting 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 Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical
1
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 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S6
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) | K161833 |
| Device Name | LATEX EXAMINATION GLOVES POWDER FREE |
| 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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
3
Image /page/3/Picture/0 description: The image shows 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 handprint inside it, placed in the middle of the word "GLOVE." Underneath the words "CARE GLOVE," the text "CAREPLUS-DESCARPACK" is written in smaller, dark blue letters.
REGLOVE GLOBAL
Senawang 3/2. Off Jalan Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Ma Fax: 60-6-6785377
K161833 510(K) SUMMARY
CAREGLOVE GLOBAL SDN BHD Applicant:
- Lot 17479, Lorong Senawang 2/3 Location 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
Summary Preparation Date: 17th May, 2017
Device Information
LATEX EXAMINATION GLOVES POWDER FREE Trade Name:
Common Name: LATEX EXAMINATION GLOVES POWDER FREE
- Classification Name: Patient Examination Gloves
Product Code: Latex – LYY
Regulation Number: 21 CFR 880.6250.
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
Intended Use of Device
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.
Brief Description of Non-Clinical Test
Testing performed as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20. The subject device meet all the ASTM D3578-05 requirements. Primary skin irritation testing in the rabbit and Closed patch sensitization testing in the guinea pig were conducted in accordance with ISO 10993-10 indicate no irritation or sensitization.
4
Image /page/4/Picture/0 description: The image shows a logo for a company called "Care Glove". The word "CARE" is in large, bold, blue letters on top. Below it, the word "GLOVE" is in a lighter green color, with a light green handprint inside the "O". Underneath that, the words "CAREPLUS-DESCARPACK" are in smaller, red letters.
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
Non-clinical laboratory and animal based test indicate that the powder free latex examination glove meets all the performance and biocompatibility requirements.
Summary of Technological Characteristic
Table 1; Comparison of Proposed and Predicate Device
| Parameter | ASTM
Specifications | Standard
References | Subject Device Measured
Values, K161833 | | Predicate
Device,
K152593 |
|------------------------------|------------------------|------------------------|--------------------------------------------|-----------------------|---------------------------------|
| | | | Value | Status | |
| Dimension | | | | | |
| Length
(size:XSmall), mm | 220 min. | ASTM D 3578-
05 | 224mm-
236mm | Meet
Specification | Meet
Specification |
| Length
(size:Small), mm | 220 min | ASTM D 3578-
05 | 225mm –
240mm | Meet
Specification | Meet
Specification |
| Length (size:
Medium), mm | 230 min | ASTM D 3578-
05 | 235mm –
246mm | Meet
Specification | Meet
Specification |
| Length (size:
Large), mm | 230 min | ASTM D 3578-
05 | 235mm –
245mm | Meet
Specification | Meet
Specification |
| Length
(size:XLarge), mm | N/A | ASTM D 3578-
05 | N/A | N/A | N/A |
| Thickness (palm),
mm | 0.08min. | ASTM D 3578-
05 | 0.12mm-
0.14mm | Meet
Specification | Meet
Specification |
| Thickness (finger),
mm | 0.08 min. | ASTM D 3578-
05 | 0.15mm-
0.17mm | Meet
Specification | Meet
Specification |
| Width (size:
XSmall) | 70 ± 10 | ASTM D3578-
05 | 73mm - 75mm | Meet
Specification | Meet
Specification |
| Width (size: Small),
mm | 80 ± 10 | ASTM D3578-
05 | 82mm-87mm | Meet
Specification | Meet
Specification |
| Width (size:
Medium), mm | 95 ± 10 | ASTM D3578-
05 | 94mm- 97mm | Meet
Specification | Meet
Specification |
| Width (size: Large),
mm | 111 ± 10 | ASTM D3578-
05 | 102mm-
107mm | Meet
Specification | Meet
Specification |
| Width (Size:
XLarge) | N/A | ASTM D3578-
05 | N/A | N/A | N/A |
5
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 of the word "GLOVE", which is written in a lighter green color. In the middle of the word "GLOVE" is a blue circle with a light green hand in the center. Underneath the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in smaller, blue letters.
CAREGLOVE GLOBAL S
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
| Parameter | ASTM
Specifications | Standard
References | Subject Device Measured | | Predicate |
|-----------------------------------------|------------------------|------------------------|-------------------------|-----------------------|-------------------------|
| | | | Values | | Device |
| | | | K161833 | | K152593 |
| | | | Value | Status | |
| Physical Properties | | | | | |
| Tensile Strength,
Before Aging, MPa | 18 min. | ASTM D 3578-
05 | 21.18MPa-
26.17MPa | Meet
Specification | Meet
Specification |
| Stress at 500%
Elongation | 5.5 MPa max. | ASTM D 3578-
05 | 3.0MPa-
4.2MPa | Meet
Specification | Meet
Specification |
| Ultimate Elongation,
Before Aging, % | 650 min. | ASTM D 3578-
05 | 750.20%-
820.20% | Meet
Specification | Meet
Specification |
| Tensile Strength,
After Aging, Mpa | 14 min. | ASTM D 3578-
05 | 18.28MPa-
23.88MPa | Meet
Specification | Meet
Specification |
| Ultimate Elongation,
After Aging, % | 500 min. | ASTM D 3578-
05 | 550.40%-
700.50% | Meet
Specification | Meet
Specification |
| Water Leak Test, 1000 ml | | | | | |
| Before Aging, AQL | 2.5 | ASTM D 3578-
05 | 1.5 and below | Meet
Specification | 1.5 and below |
| After Aging, AQL | 2.5 | ASTM D 3578-
05 | 2.5 and below | Meet
Specification | 2.5 and below |
| Extractable Protein | | | | | |
| Water Extractable
Protein, µg/dm² | 50 µg/dm² | ASTM D 5712-
10 | 50 µg/dm² and
below | Meet
Specification | 50 µg/dm² and
below |
| Residual Powder Content | | | | | |
| Residual Powder
Content, mg/glove | 2 mg/glove
max. | ASTM D 3578-
05 | 2 mg/glove and
below | Meet
Specification | 2 mg/glove
and below |
Summary of Clinical Testing
Not applicable.
Conclusions.
The conclusions drawn from nonclinical tests demonstrate that the subject device is a safe, as effective, and performs as well as or better than the legally marketed predicate device, K152593.