(455 days)
Not Found
No
The device is a simple examination glove with no mention of AI or ML capabilities in its description or performance studies.
No
The device is a patient examination glove used to prevent contamination between patient and examiner, not to treat a disease or condition.
No
The device is an examination glove, used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove made of latex, 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 "patient examination glove... to prevent contamination between patient and examiner." This is a barrier device used for protection, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The description focuses on the physical properties and manufacturing of the glove, not on any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and integrity of the glove (watertightness, tensile strength, etc.), which are relevant to its barrier function, not diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device made of natural rubber latex 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)
LYY
Device Description
The Device meets all requirements of ASTM standard D3578 and FDA 21 CFR 880.6250.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile.
The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This glove is natural in color is added) and powder free.
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 for this Glove are summarized as per below.
Physical Properties:
- Test Method: ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers- Tension)
- Purpose of Testing: To evaluate the tensile (tension) properties of glove.
- Acceptance Criteria (Before aging): Tensile strength Min 18.0 MPa, Ultimate elongation Min 650%, Stress at 500% Elongation Max. 5.5 MPa
- Acceptance Criteria (After aging): Tensile strength Min 14.0 MPa, Ultimate elongation Min 500%
- Results (Before aging):
- Tensile strength: Extra small - 24.40 MPa, Small - 24.56 MPa, Medium - 27.18 MPa, Large - 26.51 MPa, Extra Large - 26.11 MPa
- Ultimate elongation: Extra small - 792 %, Small - 808 %, Medium - 817 %, Large - 811 %, Extra Large - 783 %
- Stress at 500% Elongation: Extra small - 4.77 MPa, Small - 5.11 MPa, Medium - 4.55 MPa, Large - 4.85 MPa, Extra Large - 5.22 MPa
- Results (After aging):
- Tensile strength: Extra small - 25.59 MPa, Small - 22.37 MPa, Medium - 27.16 MPa, Large - 25.95 MPa, Extra Large - 26.67 MPa
- Ultimate elongation: Extra small - 802 %, Small - 723 %, Medium - 809 %, Large - 829 %, Extra Large -785 %
- Stress at 500% Elongation: Extra small - 4.39 MPa, Small - 4.85 MPa, Medium - 4.61 MPa, Large - 3.17 MPa, Extra Large - 5.09 MPa
- Status: Pass
Dimension:
- Test Method: ASTM D3767 Standard Practice for Rubber - Measurement of Dimensions
- Purpose of Testing: To measure the length, width and thickness of glove
- Acceptance Criteria:
- Length: Extra small – Min 240 mm, Small – Min 240 mm, Medium – Min 240 mm, Large – Min 240 mm, Extra Large – Min 240 mm
- Width: Extra small – Max 80 mm, Small – Min 80 ± 10 mm, Medium - Min 95 ± 10 mm, Large - Min 110 ± 10 mm, Extra Large – Min 110mm
- Thickness: Finger – Min 0.11 mm, Palm – Min 0.09 mm
- Results:
- Length: Extra small – 243 mm, Small – 243 mm, Medium - 243 mm, Large - 243 mm, Extra Large – 243 mm
- Width: Extra small - 78 mm, Small – 84 mm, Medium - 95 mm, Large – 106 mm, Extra Large – 116 mm
- Thickness: Finger Extra small – 0.14 mm, Small – 0.14 mm, Medium – 0.15 mm, Large – 0.15 mm, Extra Large – 0.16 mm; Palm Extra small - 0.12 mm, Small – 0.12 mm, Medium – 0.12 mm, Large – 0.12 mm, Extra Large - 0.13 mm
- Status: Pass
Watertight:
- Test Method: ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the glove.
- Acceptance Criteria:
- Size: XS, Sample size: 200 pcs, Inspection level: G1, AQL: 1.0, Acceptance No. 5, Found 0
- Size: S, Sample size: 500 pcs, Inspection level: G1, AQL: 1.0, Acceptance No. 10, Found 1
- Size: M, Sample size: 500 pcs, Inspection level: G1, AQL: 1.0, Acceptance No. 10, Found 3
- Size: L, Sample size: 500 pcs, Inspection level: G1, AQL: 1.0, Acceptance No. 10, Found 3
- Size: XL, Sample size: 200 pcs, Inspection level: G1, AQL: 1.0, Acceptance No. 5, Found 3
- Results:
- Size XS: 0 pieces were found with leaks.
- Size S: 1 piece was found with leaks.
- Size M: 3 pieces were found with leaks.
- Size L: 3 pieces were found with leaks.
- Size XL: 3 pieces were found with leaks.
- Status: Pass (all sizes fall within the acceptance criteria)
Residual Powder:
- Test Method: ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
- Acceptance Criteria: Have a powder residue limit of 2.0 mg per glove
- Results (Sample size: 5 pcs): Extra small – 0.2 mg, Small – 0.5 mg, Medium – 0.1 mg, Large – 0.1 mg, Extra Large – 0.2 mg
- Status: Pass
Extractable Protein Content:
- Test Method: ASTM D5712-99 (Standard Test Method for Analysis of Protein in Natural Rubber)
- Purpose of Testing: To determine the extractable protein in gloves
- Acceptance Criteria: 200 µg/ dm² Max
- Results (Sample size: 3 pcs): Less than 50 µg/ dm²
- Status: Pass
Shelf-life study:
- Claim: 3 years claim shelf life based on ASTM D7160.
No clinical study is included in this submission.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2022
WRP Asia Pacific SDN. BHD. % Michael Scaglione U.S. Agent SG Global, LLC 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685
Re: K211601
Trade/Device Name: Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: July 18, 2022 Received: July 19, 2022
Dear Michael Scaglione:
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. 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
1
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 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 (QS) 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 medical devices and radiation-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,
Bifeng Qian, M.D., Ph.D. 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) K211601
Device Name
Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free
Indications for Use (Describe)
A patient examination glove is a disposable device made of natural rubber latex 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
1.0 Submitter:
| Sponsor: | WRP Asia Pacific Sdn. Bhd. |
|---|---|
| Contact Name: | Muhammad Ameer Arief bin Mohd Mujab |
| Address: | WRP Asia Pacific Sdn. Bhd. |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak | |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 12th August 2022
2.0 Identification of the subject device:
| Trade Name | : Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LYY |
3.0 Predicate Device:
| PREDICATE DEVICE | |
|---|---|
| Manufacturer | Hi-Care Thai Gloves Co. Ltd. |
| Device Name | Palm Care Latex Examination Powder Free Glove |
| 510 (k) Number | K202377 |
| Regulatory Class | I |
| Product Code | LYY |
4.0 Description of The Device:
The Device meets all requirements of ASTM standard D3578 and FDA 21 CFR 880.6250.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile.
The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
5.0 Indication for use:
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Technological Characteristics Comparisons of the Device:
4
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| | | PREDICATE | CURRENT | |
| 510(k) Number | - | K202377 | K211601 | Different |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co. Ltd. | WRP Asia Pacific | Different |
| Material | ASTM D3578 | Natural rubber latex | Natural rubber latex | Similar |
| Color | - | Natural | Natural | Similar |
| Texture | - | Finger textured | Finger textured | Similar |
| Physical Properties | | Meets | Meets | |
| Before Aging
Tensile Strength:
Ultimate Elongation:
Stress at 500%
Elongation: | ASTM D3578 | 18Mpa min
650% min
5.5Mpa max | 18MPa min
650% min
5.5Mpa max | Similar |
| After Aging
Tensile Strength:
Ultimate Elongation:
Stress at 500%
Elongation: | ASTM D3578 | 14Mpa min
500% min
-
| 14MPa min
500% min
-
| Similar |
| Thickness:
- Finger
- Palm | ASTM D3578 | Meets
0.08mm min
0.08mm min | Meets
0.11mm min
0.09mm min | Different but
within the ASTM
standard |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Similar |
| CHARACTERISTICS | DEVICE PERFORMANCE | | | |
| | STANDARDS | PREDICATE | CURRENT | COMPARISON
ANALYSIS |
| Biocompatibility | Primary Skin
Irritation - ISO
10993-10:2010 (E)
& Consumer Product
Safety Commission
2012 Title 16,
Chapter II, Part
1500.3 & 1500.41 | Passes
Not a primary skin irritant
under the conditions of the
study. | Passes (Not a primary skin
irritant)
There was no erythema or oedema
noted on test site after (24±2),
(48±2) and (72±2) hours. The
primary Irritation Index (PII) was
"0". | Similar |
| | Dermal
Sensitization- ISO
10993-10: 2010 (E)
& Consumer Product
Safety Commission
2012 Title 16,
Chapter II, Part
1500.3 & 1500.41 | Passes
Not a contact sensitizer
under the conditions of the
study. | Passes (Not a contact sensitizer).
There was no positive allergic
reaction observed during the
challenge phase (at 0, 24 hours
and 48 hours) in animals treated
with the test material and
negative control. | Similar |
| | Determination of In
Vitro Cytotoxicity
Effect over L929 Cell
Lines by Direct
Contact Method, ISO
10993-5: 2009 (E) | Passes
Non-cytotoxic under the
conditions of the study. | Qualitative reactivity grading of
cytotoxicity of the test item
treatment was not greater than 2.
Hence, the test item is considered
as 'Non-cytotoxic" to L929 mouse
fibroblast cells. | Similar |
| | DEVICE PERFORMANCE | | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON
ANALYSIS |
| Biocompatibility | Acute Systemic
Toxicity, ISO
10993-11:2017 (E) | Not systemic toxic under the
conditions of the study. | It is concluded that the product
did not induce any systemic
toxicity. | Similar |
| Watertight (1000ml) | ASTM D5151 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Similar |
| 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 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
or finger to prevent
contamination between patient
and examiner. | Similar |
| Size | Medical Glove
Guidance Manual -
Labeling | Extra small
Small
Medium
Large | Extra small
Small
Medium
Large
Extra Large | Similar with
additional size, XL
for current device |
| Single use | Medical Glove
Guidance Manual -
Labeling | Single use | Single use | Similar |
| Sterility status | Medical Glove
Guidance Manual -
Labeling | Non-sterile | Non-sterile | Similar |
| Extractable Protein
Content | ASTM D5712-99 | 50 $µg/ dm²$ for all available sizes |