(116 days)
Not Found
No
The device is a patient examination glove, which is a physical barrier and does not involve any computational or analytical functions. The description focuses on material properties and physical performance tests.
No.
A patient examination glove is intended to prevent contamination, not to provide therapy or treatment.
No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, which is a hardware component. There is no mention of 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 for infection control, not a device used to diagnose a condition based on in vitro examination of specimens.
- Device Description: The description focuses on the physical properties and material of the glove, not on any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens (blood, urine, tissue, etc.), reagents, or any diagnostic procedures.
- Performance Studies: The performance studies focus on physical properties like tensile strength, dimensions, watertightness, and residual powder, which are relevant to the function of a glove as a barrier, not to diagnostic accuracy.
- Key Metrics: The key metrics are related to the physical integrity and quality of the glove, not diagnostic performance metrics like sensitivity or specificity.
In summary, the device is a medical device used for protection and infection control, not for performing in vitro diagnostic 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. 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.
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)
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
Physical Properties
- Purpose of Testing: To evaluate the tensile (tension) properties of glove.
- Standard: ASTM D412-16 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- Before aging: Min 14.0 MPa, Min 500%
- After aging: Min 14.0 MPa, Min 400%
- Results: Before aging: 24.5 MPa (Average), 547%. After aging: 26.4 MPa (Average), 449%.
- Status: Pass
Dimension
- Purpose of Testing: To measure the length, width and thickness of glove
- Standard: ASTM D3767 - 03(2014) Standard Practice for Rubber—Measurement of Dimensions
- Acceptance Criteria: Length Min 240 mm, Width Min 95 ± 10 mm, Thickness Finger – 0.05 mm Palm – 0.05 mm
- Results: Length Min 242 mm, Width 95 mm, Thickness Finger – 0.22 mm Palm – 0.21 mm
- Status: Pass
Watertight
- Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the glove.
- Standard: ASTM D5151 - 06 (Standard Test Method for Detection of Holes in Medical Gloves)
- Acceptance Criteria: Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10, Found 2
- Results: The batch size for this sampling is 150,001 to 500,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 315 pieces with accept 10 and reject 11 to be accepted under AQL 1.5. During the test, 2 pieces were found with leaks. Hence it falls within the acceptance criteria.
- Status: Pass
Residual Powder
- Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
- Standard: ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- Acceptance Criteria: Less than 2 mg per glove
- Results: Sample size : 5 pcs, Requirement :
§ 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 and 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.
January 17, 2020
Wrp Asia Pacific Sdn Bhd Hasnah Hamid Quality Assurance Manager Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 My
Re: K192635
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 24, 2019 Received: October 28, 2019
Dear Hasnah Hamid:
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,
For Elizabeth Claverie, M.S. 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) K192635
Device Name
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange)
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
1.0 Submitter:
| Name: | Hasnah Abdul Hamid |
|---|---|
| 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: 10th January 2020
2.0 I dentification of the subject device:
Trade Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves Device Classification: I Regulation Number: 21 CFR 880.6250 Product Code: LZA
3.0 Predicate Device:
K133168
Dermagrip Powder Free Blue Nitrile Examination Gloves WRP Asia Pacific Sdn Bhd
Description of The Device: 4.0
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. 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.
5.0 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.
4
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves, Non-Sterile (Orange) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | PREDICATE
BLUE | CURRRENT
ORANGE | |
| 510(k) Number | - | K133168 | K192635 | Not Available |
| Manufacturer(s) | - | WRP Asia Pacific Sdn Bhd | WRP Asia Pacific Sdn Bhd | Same |
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same |
| Color | - | Blue | Orange | Different |
| Texture | - | Finger textured
(Textured only at the finger
part) | Hand textured
(Fully textured surface from
fingertips to end of palm) | Different |
| Physical Properties | ASTM D6319-10 | | | |
| Before Aging | | | | |
| Tensile Strength : | | 14MPa min | 14MPa min | Same |
| Ultimate Elongation : | | 500% min | 500% min | |
| After Aging | | | | |
| Tensile Strength : | | 14MPa min | 14MPa min | Same |
| Ultimate Elongation : | | 400% min | 400% min | |
| Thickness - Finger | ASTM D6319-10 | 0.07-0.10mm | 0.21–0.23mm | Different |
| - Palm | | 0.07-0.09mm | 0.19-0.22mm | |
| - Cuff | | 0.06-0.08mm | 0.10-0.12mm | |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE BLUE | CURRRENT ORANGE | |
| Biocompatibility | Primary Skin Irritation -
ISO 10993-10:2002(E)
&
Consumer Product
Safety Commission,
Title 16, Chapter II, Part
1500 | 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" | 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 |
| Biocompatibility | Dermal Sensitization-
ISO 10993-10:2002 (E)
& Consumer Product
Safety Commission,
Title 16, Chapter II, Part
1500.3 (c) (4) | Passes (Not a contact
sensitizer)
There was no positive allergic
reaction observed during the
challenge phase (at 24 hours
and 48 hours) in animals
treated with the test material
and negative control. | 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 |
| Biocompatibility | Cytotoxicity — MEM
Elution,
ISO 10993-5:2009 (E) | Not available. | Exhibit severe cytotoxicity reactivity at
100%, 66%, and 44% extract
concentration.
Moderate cytotoxicity reactivity at
30%, mild cytotoxicity reactivity at
20% and slight cytotoxicity reactivity
at 15% extract concentrations.
Cytotoxicity concern was
addressed by acute systematic
toxicity testing. | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE
BLUE | CURRENT
ORANGE | |
| Biocompatibility | Acute Systemic Toxicity,
ISO 10993-11:2017 (E) | Not Available | It is concluded that the
extracts (polar and non -
polar) of the product did not
show any systemic toxicity. | Different |
| Watertight (1000ml) | ASTM D5151-06 | Inspection
Level 1, AQL 1.5 | Inspection
Level 1, AQL 1.5 | 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. | 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. | Same |
| Size | Medical Glove Guidance
Manual - Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Similar |
| Single Use | Medical Glove Guidance
Manual - Labeling | Single use | Single use | Same |
5
6
7
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for color and thickness. The current device is orange in color and thicker than predicate device.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
8
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|
| Physical | |||||||
| Properties | ASTM D412-16 | ||||||
| (Standard Test | |||||||
| Method for | |||||||
| Vulcanized Rubber | |||||||
| and Thermoplastic | |||||||
| Elastomers-Tension) | To evaluate the | ||||||
| tensile (tension) | |||||||
| properties of glove. | Before | ||||||
| aging | After | ||||||
| aging | Before | ||||||
| aging | After | ||||||
| aging | |||||||
| Min 14.0 | |||||||
| MPa | Min 14.0 | ||||||
| MPa | 24.5 MPa | ||||||
| (Average) | 26.4 MPa | ||||||
| (Average) | Pass | ||||||
| Min | |||||||
| 500% | Min | ||||||
| 400% | 547% | 449% | Pass |
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------|
| Dimension | ASTM D3767 -
03(2014)
Standard Practice
for Rubber—
Measurement of
Dimensions | To measure the
length, width
and thickness of
glove | Length
Min 240 mm | Length
Min 242 mm | Pass |
| | | | Width
Min 95 ± 10 mm | Width
95 mm | Pass |
| | | | Thickness
Finger – 0.05 mm
Palm – 0.05 mm | Thickness
Finger – 0.22 mm
Palm – 0.21 mm | Pass |
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
| Watertight | ASTM D5151 - 06
(Standard Test
Method for
Detection of Holes in
Medical Gloves) | To detect holes
that leak water
and thereby
compromise the
usefulness of | Sample size: 315 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10,
Found 2 | The batch size for this
sampling is 150,001 to
500,000. Hence,
according to the single | Pass |
9
| | | the glove. | | sampling plan GI, the
sample to be drawn is
under code M equivalent
to 315 pieces with accept
10 and reject 11 to be
accepted under AQL 1.5.
During the test, 2 pieces
were found with leaks.
Hence it falls within the
acceptance criteria. | |
| -- | -- | ------------ | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------|--------|
| Residual
Powder | ASTM D6124-06
(Standard Test
Method for Residual
Powder on Medical
Gloves) | To determine
the amount of
residual powder
and non-powder
solids found on
gloves. | Less than 2 mg per glove | Sample size : 5 pcs
Requirement :