(127 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of surgical gloves, with no mention of AI or ML.
No.
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
The device description and intended use state that it is a surgical glove for protection, not for diagnosing any medical condition.
No
The device description explicitly states it is made of natural rubber latex and describes physical characteristics and bench testing related to material properties and performance, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties and materials of the glove, its sterility, and its intended use as a protective barrier. There is no mention of analyzing samples or providing diagnostic information.
- 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 prognosis of a disease or condition
- Using reagents or calibrators
The device described is a medical device intended for surgical use as a protective barrier.
N/A
Intended Use / Indications for Use
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color is added).
The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
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
operating room personnel
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)
Bench tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the standard or test methodology. The test results demonstrated that the proposed device complies with the following standards:
- ASTM (Reapproved 2015), Standard Specification for Rubber Surgical Gloves, for length, width, thickness, tensile strength, and ultimate elongation.
- ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves, for pinhole AQL.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves, for powder content.
- ASTM D5712-15, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber, for protein content.
Biocompatibility tests were conducted as per ISO 10993 series and USP standards:
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-5:2009(E): Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity.
- ISO 10993-11:2017(E): Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
- USP 41 : Pyrogen Test (Material Mediated Pyrogenicity).
- USP 42 : Bacterial Endotoxin Test.
Clinical data was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: Min 265mm for all sizes. Results for subject device range from 385mm to 396mm.
- Width: Ranges from 76+/-6mm to 114+/-6mm depending on size. Results for subject device range from 74mm to 116mm.
- Finger Thickness (All sizes): Min 0.10mm. Subject device: 0.20mm.
- Palm Thickness (All sizes): Min 0.10mm. Subject device: 0.15mm.
- Cuff Thickness (All sizes): Min 0.10mm. Subject device: 0.12mm.
- Tensile Strength Before aging (All sizes): 24 MPa minimum. Subject device: 28.55 MPa.
- Tensile Strength After aging @ 70°±2C for 166±2 hr (All sizes): 18 MPa minimum. Subject device: 23.48 MPa.
- Ultimate Elongation Before aging (All sizes): 750% minimum. Subject device: 870%.
- Ultimate Elongation After aging @ 70°±2C for 166±2 hr (All sizes): 560% minimum. Subject device: 731%.
- Stress at 500% before ageing (All sizes): 5.5 MPa Max. Subject device: 5.1 MPa.
- Pinhole AQL (All sizes): Max 1.5. Subject device: 1.0.
- Powder residue for powder free glove (All sizes): Powder content ≤ 2 mg/Glove. Subject device: 0.40 mg/Glove.
- Protein Content: ≤ 50 µg/dm². Subject device: 38 µg/dm².
- Skin Irritation & Skin Sensitization: Non-irritant and Non-Sensitizer.
- In vitro cytotoxicity: Cytotoxic.
- Material Mediated pyrogenicity: Non pyrogenic.
- Systemic Toxicity: Under the conditions of study the device extracts do not pose a systemic toxicity concern.
- Bacterial Endotoxin:
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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.
September 16, 2021
Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K211478
Trade/Device Name: Sterile Latex Surgical Gloves powder free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: August 16, 2021 Received: August 16, 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,
Clarence W. Murray III -S
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211478
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| 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) |
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3
510K SUMMARY K211478 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Aspen Glove Sdn. Bhd. |
|---|---|---|
| 2 | Date Submitted | 14 September 2021 |
| 3 | Address | Aspen House, 300, JLN Macalister, |
| 10450 Georgetown, Pulau Pinang, Malaysia | ||
| 4 | Phone | +604- 227 5000 |
| 5 | Fax | +604- 227 5000 |
| 6 | corporate@aspen.com.my | |
| 7 | Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| 8 | Designation | Managing Director |
| 9 | Contact Number | 017 -550 0577 |
| 10 | Contact Email | Iskandar@aspenglove.com.my |
B. US AGENT & CONTACT PERSON INFORMATION
| 11 | US agent &
contact person name | Manoj Zacharias |
|----|-----------------------------------|----------------------------------------------------------------------------------|
| 12 | Address | Liberty Management Group Ltd.
75 Executive Dr. STE 114 Aurora, IL-60504, USA. |
| 13 | Phone | (630) 270-2921 |
| 14 | Fax | (815) 986-2632 |
| 15 | E-mail | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 16 | Common Name | Surgeon's Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary or trade name | AspenMed+S | |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Regulation Name | Non-Powdered Surgeon's Glove |
| 23 | Review Panel | Gen & Plastic Surgery |
4
D. PREDICATE DEVICE INFORMATION
| Description | Name of device | 510k
Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Predicate
device | JR Medic Latex Surgeon's Gloves
Sterile Powder Free with protein
content labeling claim of 50 µg/
dm² or less per glove of
extractable protein | K192328 | JR Engineering & Medical
Technologies (M) SDN.
BHD.
Lot 8 &10, Jalan Zurah 3
& Lot 1&3, Jalan Zurah
3A/1, Pusat Perindustrian
2, 44200 Rasa, Hulu
Selangor, Selangor Darul
Ehsan, Malaysia. |
E. DESCRIPTION OF THE DEVICE
The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of differentsizes.
All variants share the same natural color (No color is added).
The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
F. INDICATION FOR USE:
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
5
G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| Characteristic | Subject device | Predicate device | Comparison |
|---|---|---|---|
| K211478 | K192328 | ||
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | Same |
| Intended Use | A Sterile Latex Surgical | ||
| Gloves Powder Free is a | |||
| device made of natural | |||
| rubber intended to be worn | |||
| by operating room | |||
| personnel to protect a | |||
| surgical wound from | |||
| contamination. | A latex surgeon's glove is | ||
| a device made of natural | |||
| rubber intended to be | |||
| worn by operating room | |||
| personnel to protect a | |||
| surgical wound from | |||
| contamination. | Similar | ||
| Powdered or Powder | |||
| free | Powder free | Powder free | Same |
| Classification as per | |||
| ASTMD3577-09, | |||
| Standard | |||
| Specification for | |||
| Rubber Surgical | |||
| Gloves | Type I - gloves | ||
| compounded primarily | |||
| from natural rubber latex | Type I - gloves | ||
| compounded primarily | |||
| from natural rubber latex | Same | ||
| Sterilization | Radiation, | ||
| SAL- 10-6 | Radiation, | ||
| SAL- 10-6 | Same | ||
| Label and Labeling | Meet FDA's label | ||
| Requirements | Meet FDA's label | ||
| Requirements | Same | ||
| Special label claim | Protein content labeling | ||
| claim of 50µg/dm² or less | |||
| per glove of extractable | |||
| protein for Latex Surgeon's | |||
| Gloves Powder Free. | Protein content labeling | ||
| claim of 50µg/dm² or less | |||
| per glove of extractable | |||
| protein for Latex | |||
| Surgeon's | |||
| Gloves | |||
| Powder Free. | Same | ||
| Type of use | Over the counter use | Over the counter use | Same |
a. General Characteristics Comparison
6
b. Technological Characteristics Comparison
| SI.
No | Criteria | Specification as
per ASTMD
3577-09,
Standard
Specification
for Rubber
Surgical Gloves | Subject
device
K211478 | Predicate
device
K192328 | Comparison |
|-----------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | | | | | |
| Length | | | | | |
| | Size 6 | Min 265mm | 385mm | 306mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber
Surgical Gloves |
| | Size 6'/2 | Min 265mm | 386mm | 306mm | |
| | Size 7 | Min 265mm | 388mm | 305mm | |
| | Size 7'/2 | Min 265mm | 390mm | 305mm | |
| | Size 8 | Min 265mm | 392mm | 305mm | |
| | Size 8'/2 | Min 265mm | 394mm | 305mm | |
| | Size 9 | Min 265mm | 396mm | 305mm | |
| 2 | | | | | |
| Width | | | | | |
| | Size 6 | 76+/-6mm | 74mm | 78mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber
Surgical Gloves |
| | Size 6'/2 | 83+/-6mm | 86mm | 85mm | |
| | Size 7 | 89+/-6mm | 92mm | 88mm | |
| | Size 7'/2 | 95+/-6mm | 98mm | 97mm | |
| | Size 8 | 102+/-6mm | 103mm | 103mm | |
| | Size 8'/2 | 108+/-6mm | 110mm | 110mm | |
| | Size 9 | 114+/-6mm | 116mm | 116mm | |
| 3 | Finger
Thickness
(All sizes) | Min 0.10mm | 0.20mm | 0.21mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber
Surgical Gloves |
| 4 | Palm
Thickness
(All sizes) | Min 0.10mm | 0.15mm | 0.18mm | |
| 5 | Cuff
Thickness
(All sizes) | Min 0.10mm | 0.12mm | 0.11mm | |
| SI.
No | Criteria | Specification as per ASTMD
3577-09, Standard
Specification for Rubber Surgical
Gloves | Average Value of
Subject device
K211478 | Average Value of
Predicate device
K192328 | Comparison |
| 6 | Tensile Strength | | | | |
| | Before aging
(All sizes) | 24 Mpa minimum | 28.55 Mpa | 26.00 Mpa | Similar Meets ASTM
D3577-
09(Reapproved 2015), Standard
Specification for Rubber
Surgical Gloves |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 18 Mpa minimum | 23.48 Mpa | 22.00 Mpa | |
| 7 | Ultimate Elongation | | | | |
| | Before aging
(All sizes) | 750% minimum | 870% | 860% | |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 560% minimum | 731% | 725% | Similar Meets ASTM
D3577-09
(Reapproved 2015), Standard
Specification for Rubber
Surgical Gloves |
| 8 | Stress at
500% before
ageing
(All sizes) | 5.5 MPa Max | 5.1 Mpa | 2.7 Mpa | |
| 9 | Pinhole AQL | | | | |
| | Before aging
(All sizes) | Max 1.5 | 1.0 | 1.0 | Similar
Meets ASTM
D3577-09 (15) and
ASTM D5151-06,
( Reapproved
2015), Standard Test
Method for Detection of
Holes in Medical Gloves |
| | After aging@
70°C for 7
days
(All sizes) | Max 1.5 | 1.0 | 1.0 | |
| SI.
No | Criteria | Specification as
per ASTMD
3577-09,
Standard
Specification for
Rubber Surgical
Gloves | Average
Value of
Subject
device
K211478 | Average
Value of
Predicate
device
K192328 | Comparison |
| 10 | | | Powder Content | | |
| | Powder
residue for
powder free
glove
(All sizes) | Powder content
$\leq$ 2 mg/Glove | 0.40
mg/Glove | 0.34
mg/Glove | Similar
Meets ASTM D3577 and
ASTM D6124-06,(
Reapproved 2017),
Standard Test Method for
Residual Powder on
Medical Gloves |
| 11 | Protein Content | | | | |
| | Protein
Content | $\leq$ 50 µg/ dm² | 38 µg/ dm² | 43 µg/ dm² | Similar
Meets ASTM D3577,
ASTM D5712-15,
Standard Test Method for
the Analysis of Aqueous
Extractable Protein in
Natural
Rubber |
7
8
c. Biocompatibility Comparison
| Biocompatibility | Test Method | Subject
device
K211478 | Predicate device
K192328 | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------|------------|
| Skin Irritation &
Skin
Sensitization | ISO 10993-
10,Biological
evaluation of medical
devices - Part 10:
Tests for irritation and
skin sensitization | Non- irritant
and Non-
Sensitizer | Non- irritant and
Non-Sensitizer | Same |
9
| Biocompatibility | Test Method | Subject device
K211478 | Predicate device
K192328 | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------|------------|
| In vitro
cytotoxicity | ISO 10993-
5:2009(E),Biological
Evaluation of Medical
Devices - Part 5-Tests
for in vitro
Cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material
Mediated
pyrogenicity | ISO 10993-
11:2017(E),
Biological Evaluation
of Medical Devices -
Part 11, Tests for
Systemic Toxicity and
USP 41
Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| Systemic
Toxicity | ISO 10993-
11:2017(E),
Biological Evaluation
of Medical Devices -
Part 11, Tests for
Systemic Toxicity | Under the
conditions
of study the
device extracts
do not pose a
systemic
toxicity
concern | No data available | ---- |
| Bacterial
Endotoxin | USP 42 | | To determine the pyrogenic
potential of the test item
extract
following
intravenous injection in New
Zealand white Rabbits. | Under
the
conditions of
the study, the
device did not
demonstrate a
material
mediated
pyrogenicity
response. | Under the
conditions of the study,
the device did not
demonstrate a material
mediated
pyrogenicity response. |
| Bacterial Endotoxin
test USP 42 | To determine the Bacterial
Endotoxin limit in the glove | NMT 20
EU/pair of
gloves |