(245 days)
Not Found
No
The device is a simple patient examination glove and the description focuses on material properties and physical characteristics, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination. It does not treat or alleviate any condition or disease.
No
The device is a medical glove, a barrier device intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical patient examination glove, not a software application. The description details the material, manufacturing process, and physical characteristics of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for protection, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical characteristics and manufacturing process of a glove. It doesn't mention any components or functions related to analyzing 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 substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, Patient Examination Glove, which is a classification for medical devices used as barriers, not for in vitro diagnostics.
In summary, the device is a physical barrier intended for protection during patient examination, not a tool for performing diagnostic tests on biological samples.
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
The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.
They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.
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 / 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)
The performance test data of the non-clinical test demonstrates that the subject device met the specifications and the acceptance criteria of the test method or standards shown in the table below:
Test Methodology: ASTM D3578, ASTM D5151
Purpose: Freedom From Holes
Acceptance Criteria: Meet requirement inspection level G-I, AQL 2.5
Results: Pass
Test Methodology: ASTM D3578
Purpose: Dimension
Acceptance Criteria: Size XS S M L XL Length, min. mm 220 230 NA Thickness, min. mm finger 0.08 NA palm 0.08 NA Width, ± 10 mm 70 80 95 111 NA
Results: Pass
Test Methodology: ASTM D3578
Purpose: Physical Properties
Acceptance Criteria: Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Stress at 500% Elongation Tensile Strength Ultimate Elongation 18 MPa min. 650% min. 5.5 MPa min. 14 MPa min. 500% min.
Results: Pass
Test Methodology: ASTM D3578, ASTM D6124
Purpose: Powder Content
Acceptance Criteria: Not more than 2mg per glove
Results: Pass
Test Methodology: ASTM D3578, ASTM D5712
Purpose: Protein Content
Acceptance Criteria: This glove contains 50 µg/g or less per glove of total aqueous extractable protein
Results: Pass
Test Methodology: ISO10993-10
Purpose: Biocompatibility Primary Skin Irritation Test
Acceptance Criteria: Not a skin irritant under the conditions of test.
Results: Pass
Test Methodology: Not specified (under ISO10993-10)
Purpose: Dermal Sensitization Test
Acceptance Criteria: Not a skin sensitizer under the conditions of test
Results: Pass
Test Methodology: ISO 10993-11
Purpose: Biocompatibility Acute Systemic Toxicity
Acceptance Criteria: Did not reveal systemic toxicity under the conditions of test.
Results: Pass
Clinical testing is not applicable to this device.
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/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue rectangle with the letters "FDA" in white. To the right of the rectangle, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 20, 2021
Careplus (M) SDN BHD Lim Shyan CEO/ Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K203705
Trade/Device Name: Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: July 19, 2021 Received: July 21, 2021
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Liqun Zhao -S
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203705
Device Name
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 µg/g or less of total extractable protein)
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Applicant: | CAREPLUS (M) SDN BHD |
|---|---|
| Address: | Lot 120 & 121, Jalan Senawang 3, |
| Senawang Industrial Estate, | |
| 70450 Seremban, | |
| Negeri Sembilan Darul Khusus, | |
| Malaysia. | |
| Phone No. | 60-6-6772781 Fax No. 60-6-6772780 |
| Contact Person | Lim Kwee Shyan |
| Date of Summary | 13th July, 2021 |
| Trade Name: | Latex Examination Glove, Powder free with Protein Content Labeling |
| Claim (50 µg/g or less of total extractable protein) | |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
Device Description
The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.
They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.
Predicate device
The device and the predicate device, Latex Examination Gloves, Powder Free, 510(k) number K152593, share the same intended use, same material and same compliance with standards. The only difference in this submission is to include the Protein Labelling Claim (50 µg/g or less of total extractable protein) with no changes in the manufacturing process and product design.
Indication 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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Technological comparison Table:
| Characteristics | Standard
Reference | ASTM
Specifications | Subject Device
Measured
Values
(510(k)
K203705) | Predicate Device
K152593 | Characteristics |
|-------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------|
| Dimension | ASTM D3578 | | | | |
| Length, mm | | XS, S- 220min.
M, L-230 min.
XL- NA | min. 240mm
min. 240mm
min. 240mm | Meet Specification | Same |
| Thickness (palm), mm | | 0.08min. | min. 0.13mm | Meet Specification | |
| Thickness (finger), mm | | 0.08 min. | min. 0.14mm | Meet Specification | |
| Width (size:
X-Small), mm | | 70 ± 10 | 75mm-76mm | Meet Specification | |
| Width (size: Small), mm | | 80 ± 10 | 84mm-86mm | Meet Specification | |
| Width (size: Medium),
mm | | 95 ± 10 | 96mm- 97mm | Meet Specification | |
| Width (size: Large), mm | | 111 ± 10 | 107-108mm | Meet Specification | |
| Width (size:
X-Large), mm | | NA | 117-119mm | Meet Specification | |
| Physical Properties
(Before Aging) | ASTM D3578 | | | | |
| i) Tensile Strength, Mpa | | 18 min. | min. 24 Mpa | Meet Specification | Same |
| ii) Stress at 500%
Elongation | | 5.5 MPa max. | max.3.3Mpa | | |
| iii) Ultimate Elongation
(After Aging) | | 650 min. | min. 750% | | |
| i) Tensile Strength, Mpa | | 14 min. | min. 18Mpa | Meet Specification | Same |
| ii) Ultimate Elongation, | | 500 min. | min. 750% | | |
| Protein Content | ASTM D3578
ASTM D5712 | 200 µg/dm² max. | 50 µg/g and
below | Meet Specification | Same |
| Freedom from holes | ASTM D3578
ASTM D5151 | G-1, AQL 2.5 | 2.5 and below | Meet Specification | Same |
| Residual Powder | ASTM D3578
ASTM D6124 | 2 mg/glove max. | 2 mg/glove and
below | Meet Specification | Same |
| Biocompatability Test | | ISO10993-10 | | | |
| Skin Irritation Test | n.a | n.a | Passed | | Same |
| Dermal Sensitization
Test | n.a | n.a | Passed | | Same |
| Acute Systemic Study | | ISO10993-11 | Acute Systemic Toxicity study.
Conclusion: Under the conditions of this
study, the test material both inner and
outer surface did not reveal systemic
toxicity. | | Same |
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| No. | Characteristic | Subject Device, K203705
Latex Examination Gloves, Powder Free with Protein
Content Labeling Claim (50 µg/g or less of total
extractable protein) | Predicate Device
K152593 | |
|-----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 1 | Product Code | LYY | Same | |
| 2 | Regulation Number | 21 CFR 880.6250 | Same | |
| 3 | Device Class | Class 1 | Same | |
| 4 | Indication 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. | Same | |
| 5 | Design | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff | Same | |
| 6 | Construction | Ambidextrous, Powder Free Latex | Same | |
| 7 | Color | Natural | Same | |
| 8 | Materials | Latex | Same | |
| 9 | Single Use | Single use only | Same | |
| 10 | Packaging | Packed in Dispenser Boxes | Same | |
| 11 | Performance | I) Freedom From Holes
II) Dimension
III) Physical Properties
IV) Residual Powder
V) Biocompatability Test
Primary Skin Irritation Test
Dermal Sensitization Test | Meets ASTM D 3578
Meets ASTM D 3578
Meets ASTM D 3578
Meets ASTM D 3578
Under the conditions of the study, not an irritant.
Under the conditions of the study, not a sensitizer. | Same
Same
Same
Same
Same |
| 12 | Labeling Claim | i) No Chemotherapy Drugs Labeling Claim
ii) With Protein Labeling Claim | i) Same
ii) Different. No Protein
Labeling Claim | |
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Summary of Non-Clinical Testing
The performance test data of the non-clinical test demonstrates that the subject device met the specifications and the acceptance criteria of the test method or standards shown in the table below:
| Test
| Methodology | Purpose | Acceptance Criteria | Results | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D3578 | |||||||||||||||||||||||||||||||||
| ASTM D5151 | Freedom From | ||||||||||||||||||||||||||||||||
| Holes | Meet requirement inspection level G-I, AQL 2.5 | Pass | |||||||||||||||||||||||||||||||
| ASTM D3578 | Dimension | Size XS S M L XL Length, min. mm 220 230 NA Thickness, min. mm | |||||||||||||||||||||||||||||||
| finger 0.08 NA palm 0.08 NA Width, ± 10 mm 70 80 95 111 NA | Pass | ||||||||||||||||||||||||||||||||
| ASTM D3578 | Physical | ||||||||||||||||||||||||||||||||
| Properties | Before Aging After Accelerated Aging Tensile | ||||||||||||||||||||||||||||||||
| Strength Ultimate | |||||||||||||||||||||||||||||||||
| Elongation Stress at 500% | |||||||||||||||||||||||||||||||||
| Elongation Tensile | |||||||||||||||||||||||||||||||||
| Strength Ultimate | |||||||||||||||||||||||||||||||||
| Elongation 18 MPa min. 650% min. 5.5 MPa min. 14 MPa min. 500% min. | Pass | ||||||||||||||||||||||||||||||||
| ASTM D3578 | |||||||||||||||||||||||||||||||||
| ASTM D6124 | Powder Content | Not more than 2mg per glove | Pass | ||||||||||||||||||||||||||||||
| ASTM D3578 | |||||||||||||||||||||||||||||||||
| ASTM D5712 | Protein Content | This glove contains 50 µg/g or less per glove of total aqueous extractable | |||||||||||||||||||||||||||||||
| protein | Pass | ||||||||||||||||||||||||||||||||
| ISO10993-10 | Biocompatibility | ||||||||||||||||||||||||||||||||
| Primary Skin | |||||||||||||||||||||||||||||||||
| Irritation Test | Not a skin irritant under the conditions of test. | Pass | |||||||||||||||||||||||||||||||
| Dermal | |||||||||||||||||||||||||||||||||
| Sensitization | |||||||||||||||||||||||||||||||||
| Test | Not a skin sensitizer under the conditions of test | ||||||||||||||||||||||||||||||||
| ISO 10993-11 | Biocompatibility | ||||||||||||||||||||||||||||||||
| Acute Systemic | |||||||||||||||||||||||||||||||||
| Toxicity | Did not reveal systemic toxicity under the conditions of test. | Pass |
Summary of Clinical Testing
Clinical testing is not applicable to this device.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject in 510(k) K203705, Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 µg/g or less of total extractable protein) is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.