(121 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, Blue Nitrile Examination Gloves, is intended to prevent contamination and is described as a Class I patient examination glove. Its function is not to treat or diagnose a disease or condition.
No
Explanation: The device is a glove intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical product (gloves) and not software. The description clearly outlines the material and physical properties of the gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description identifies the device as "Class I patient examination gloves." Examination gloves are a physical barrier, not a tool for diagnosing conditions.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties, integrity, and biocompatibility – characteristics relevant to a barrier device, not a diagnostic one.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Not Found
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 testing was performed according to ASTM D6319-2019 for dimensions (length, width, thickness), physical properties (tensile strength, ultimate elongation), and water tight integrity (ASTM D5151-2019). The powder residue was tested according to ASTM D6124-06 (Reapproved 2017). Biocompatibility testing included primary skin irritation (ISO 10993-10:2010(E)), dermal sensitization (ISO 10993-10:2010(E)), in vitro cytotoxicity (ISO 10993-5:2009(E)), acute systemic toxicity (ISO 10993-11:2017(E)), and bacterial endotoxin test (USP 42). All tests demonstrated that the device meets the specified acceptance criteria and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: Min 230 mm for all sizes (X-Small: 246 mm, Small: 246 mm, Medium: 248 mm, Large: 248 mm, X-Large: 250 mm)
- Width: X-small: 70 +/- 10 mm, Small: 80 +/- 10 mm, Medium: 95 +/- 10 mm, Large: 110 +/- 10 mm, X-Large: 120 +/- 10 mm (X-small: 68 mm, Small: 80 mm, Medium: 92 mm, Large: 105 mm, X-Large: 115 mm)
- Thickness: Palm 0.05 mm min, Finger 0.05 mm min for all sizes (X-Small: 0.12mm (Palm), 0.20mm (Finger); Small: 0.12mm (Palm), 0.20mm (Finger); Medium: 0.12mm (Palm), 0.20mm (Finger); Large: 0.12mm (Palm), 0.20mm (Finger); X-Large: 0.12mm (Palm), 0.20mm (Finger))
- Tensile strength (Before Ageing): 14Mpa Min for all sizes (X-Small: 18.45Mpa, Small: 18.54Mpa, Medium: 18.62Mpa, Large: 18.67Mpa, X-Large: 18.72Mpa)
- Tensile strength (After Ageing): 14Mpa Min for all sizes (X-Small: 17.54Mpa, Small: 17.56Mpa, Medium: 17.68Mpa, Large: 17.75Mpa, X-Large: 17.80Mpa)
- Ultimate Elongation (Before Ageing): 500% Min for all sizes (X-Small: 686%, Small: 690%, Medium: 694%, Large: 702%, X-Large: 705%)
- Ultimate Elongation (After Ageing): 400% Min for all sizes (X-Small: 659%, Small: 665%, Medium: 668%, Large: 670%, X-Large: 674%)
- Holes (Water Tight): AQL 1.5 (Passes AQL 1.5)
- Residual Powder: 2 Mg/Glove Max (X-small: 0.21mg/glove, Small: 0.21mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove)
- Biocompatibility: Not an irritant, not a sensitizer, cytotoxic (in vitro), no systemic toxicity concern, Bacterial Endotoxin
§ 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/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 6, 2022
Pentavest Holdings Sdn Bhd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K212847
Trade/Device Name: Penta Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 1, 2021 Received: September 7, 2021
Dear Manoj Zacharias:
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 Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212847
Device Name
Penta Glove
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | ☐ Residential Use (Part 1 CFR 201, Subpart D)☑ Day-Care Use (Part 1 CFR 201, Subpart G) | ☐ Residential Use (Part 1 CFR 201, Subpart D) | ☑ Day-Care Use (Part 1 CFR 201, Subpart G) |
|---|---|---|---|
| ☐ Residential Use (Part 1 CFR 201, Subpart D) | ☑ Day-Care Use (Part 1 CFR 201, Subpart G) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY As required by: 21CFR§807.92(c)
| 510(K) Owner's Name | Pentavest Holdings Sdn Bhd |
|---|---|
| Address | No. 9574-9578, Jalan PTB 2 , |
| Kawasan Perindustrian Tangga, | |
| Batu , 76400 Melaka, Malaysia | |
| Phone | +601 22332689 |
| Fax | --- |
| bjteng@pentavest.com.my | |
| Contact Person | Teng Boon Joo |
| Designation | Managing Director |
| Contact Number | +601 22332689 |
| Contact Email | bjteng@pentavest.com.my |
| Date Submitted | 01 September 2021 |
A. APPLICANT INFORMATION
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | PENTA GLOVE |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | ---- | ||
| Name of device | JR MEDIC Blue Nitrile | |||
| Examination Gloves | ||||
| Powder-free | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free | ---- | |||
| Dimensions | ASTMD 6319-2019 | Length Min 230 m Width | ||
| Min 95+/-10 | ||||
| mm(for medium size) | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm(for medium size) | Same | |||
| Physical Properties | ASTMD 6319-2019 | Before Aging | ||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Before Aging | |||
| Tensile Strength min | ||||
| 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ASTMD 6319-2019 | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Residue | ASTMD 6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin | |||
| Irritation- | ||||
| ISO 10993- | ||||
| 10:2010(E) | Under the condition of | |||
| study not an irritant | Under the condition | |||
| of study not an | ||||
| irritant | Same | |||
| Dermal | ||||
| Sensitization- ISO | ||||
| 10993-10:2010(E) | Under the conditions of | |||
| the study not a sensitizer | Under the conditions | |||
| of the study not a | ||||
| sensitizer | Same | |||
| In vitro cytotoxicity | ||||
| ISO10993-5 | ||||
| :2009(E) | Under the conditions | |||
| of the study, cytotoxic | Under the conditions | |||
| of the study, | ||||
| cytotoxic | Same | |||
| Acute Systemic | ||||
| Toxicity Test ISO | ||||
| 10993-11:2017(E) | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity concern | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity | ||||
| concern | Same | |||
| Bacterial Endotoxin | ||||
| test USP 42 | No data available | To determine the Bacterial | ||
| Endotoxin limit in the glove | NMT 20 EU/pair of | |||
| gloves |