(118 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
Therapeutic devices are used to treat diseases or conditions, whereas these gloves are intended to prevent contamination and protect the examiner, which is a diagnostic/protective function, not therapeutic.
No
Explanation: The device is a patient examination glove, described as a preventative measure to avoid contamination between patient and examiner. It is not used to diagnose a medical condition.
No
The device is a physical examination glove made of nitrile rubber, clearly described as a tangible, disposable product worn on the hand. It does not involve any software components.
Based on the provided text, 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 to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the gloves (material, size, features) and their function as a barrier. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic results
- Using reagents or assays
- Measuring analytes
The device is a medical device, specifically a patient examination glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
For Device Candidate #1: Nitrile Powder Free Examination Gloves
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.
For Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
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. These gloves were tested for use with the following chemotherapy drugs as per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) 3.3 mg/ml: no breakthrough up to 32.9 minutes
Cisplatin 1.0mg/ml: no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) 20.0mg/ml: no breakthrough up to 240 minutes
Dacarbazine 10.0mg/ml: no breakthrough up to 240 minutes
Doxorubicin HCl 2.0mg/ml: no breakthrough up to 240 minutes
Etoposide 20.0mg/ml: no breakthrough up to 240 minutes
Fluorouracil 50.0mg/ml: no breakthrough up to 240 minutes
Ifosfamide 50.0mg/ml: no breakthrough up to 240 minutes
Methotrexate 25.0mg/ml: no breakthrough up to 240 minutes
Mitomycin C 0.5mg/ml: no breakthrough up to 240 minutes
Paclitaxel 6.0mg/ml: no breakthrough up to 240 minutes
ThioTepa 10.0mg/ml: no breakthrough up to 35.7 minutes
Vincristine Sulfate 1.0mg/ml: no breakthrough up to 240 minutes
Product codes
LZA, LZC
Device Description
Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
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)
Summary of Non-Clinical Tests:
- Watertight Test (Freedom from Holes) as per ASTM D5151: Pass Inspection Level G1, AQL 2.5
- Dimensions as per ASTM D6319: Meet requirements for length (min 220mm-230mm depending on size), palm width (70 ± 10mm to 130 ± 10mm depending on size), and thickness (min 0.05mm for finger and palm).
- Physical Properties as per ASTM D6319:
- Before Aging: Tensile strength: min 14MPa, Ultimate elongation: min 500%
- After Aging: Tensile strength: min 14MPa, Ultimate elongation: min 400%
- Powder Amount as per ASTM D6124: Residual powder
§ 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.
May 12, 2022
KL-Kepong Rubber Products SDN. BHD. % Kewin Tham Official Correspondent mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K220118
Trade/Device Name: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC Dated: April 6, 2022 Received: April 11, 2022
Dear Kewin Tham:
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.
1
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 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. Acting 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) K220118
Device Name Nitrile Powder Free Examination Gloves
Indications for Use (Describe)
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.
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
K220118
Date Summary Prepared: 12 May 2022
1. Submitter's Identification:
KL-KEPONG RUBBER PRODUCTS SDN. BHD. Lot 134905, ¾ Mile Off Jalan Bercham, Kawasan Perindustrian Bercham, 31400 Ipoh, Perak, Malaysia
Contact: Michael Ng Seng Chuenq Tel: +605-5417337
2. Name of the Devices:
Name of Device Candidate #1: Nitrile Powder Free Examination Gloves
Name of Device Candidate #2:
Chemotherapy Nitrile Powder Free Examination Gloves
3. Regulatory Information:
For Device Candidate #1:
Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:
Polymer Patient Examination Glove Class I LZA 21 CFR 880.6250 General Hospital
For Device Candidate #2:
Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:
Patient Examination Glove, Specialty Class I LZC 21 CFR 880.6250 General Hospital
4. Predicate Device Information:
For both Device Candidate #1 and Device Candidate #2:
Predicate Device: K182851
4
| Trade/Device Name: | SkyBreeze Zero Nitrile Powder-Free Exam Gloves Tested
for Use with Chemotherapy Drugs |
|-----------------------------|------------------------------------------------------------------------------------------|
| Device Classification Name: | Patient Examination Glove |
| Device Class: | Class I |
| Product Code: | LZA, LZC |
| Applicant Name: | O&M Halyard, Inc. |
5. Device Description:
Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These qloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy druq labeling.
6. Indications for Use:
1. Device Candidate #1: Nitrile Powder Free Examination Gloves
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.
-
- Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs as per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
- Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
Carmustine (BCNU) 3.3 mg/ml: no breakthrough up to 32.9 minutes Cisplatin 1.0mg/ml: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20.0mg/ml: no breakthrough up to 240 minutes Dacarbazine 10.0mg/ml: no breakthrough up to 240 minutes Doxorubicin HCl 2.0mq/ml: no breakthrough up to 240 minutes Etoposide 20.0mg/ml: no breakthrough up to 240 minutes Fluorouracil 50.0mg/ml: no breakthrough up to 240 minutes Ifosfamide 50.0mg/ml: no breakthrough up to 240 minutes Methotrexate 25.0mg/ml: no breakthrough up to 240 minutes
5
Mitomycin C 0.5mg/ml: no breakthrough up to 240 minutes Paclitaxel 6.0mg/ml: no breakthrough up to 240 minutes ThioTepa 10.0mg/ml: no breakthrough up to 35.7 minutes Vincristine Sulfate 1.0mg/ml: no breakthrough up to 240 minutes
Not recommended for use: Carmustine (BCNU) 3.3mg/ml, ThioTepa 10.0mg/ml
7. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| COMPARISON
CRITERIA | Subject Device | Predicate Device
(K182851) | COMPARISON
RESULTS |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | KL-Kepong Rubber
Products Sdn. Bhd. | O&M Halyard, Inc. | N/A |
| Device Classification
Name/ Regulation
Number | Patient Examination
Glove/ 21 CFR Part
880.6250 | Patient Examination
Glove/ 21 CFR Part
880.6250 | Similar |
| Product Code | LZA, LZC | LZA, LZC | 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. These
gloves were tested for
use with
chemotherapy drugs
as per ASTM D6978-
05 (2019) Standard
Practice for
Assessment of
Resistance of Medical
Gloves to Permeation
by Chemotherapy
Drugs. | The SkyBreeze Zero
Nitrile Powder-Free
Exam Glove is a
disposable device
intended for medical
purposes that is worn
on the examiner's hand
to prevent
contamination between
patient and examiner.
These gloves were
tested for use with
chemotherapy drugs
listed on the label | Similar |
| Material | Nitrile | Nitrile | Similar |
| Powdered or powder
free | Powder free | Powder free | Similar |
| Single use | Yes | Yes | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Dimensions | Meet requirements of
ASTM D6319 | Meet requirements of
ASTM D6319 | Similar |
| Physical properties | Meet requirements of | Meet requirements of | Similar |
| | ASTM D6319 | ASTM D6319 | |
| Freedom from Holes | Meet requirements of
ASTM D5151 | Meet requirements of
ASTM D5151 | Similar |
| Residual Powder | Meet requirements of
ASTM D6124 | Meet requirements of
ASTM D6124 | Similar |
| Chemotherapy Drugs
Permeation Test as per
ASTM D6978, minimum
breakthrough detection
time in minutes (for
Device Candidate #2) | Meets acceptance
criteria for 11 drugs | Meets acceptance
criteria for 10 drugs | Minimum 9 drugs
meeting
acceptance
criteria.
Similar |
| | Carmustine (BCNU),
3.3 mg/ml: 32.9 | Carmustine (BCNU),
3.3 mg/ml: 18.6 | 240 | Cisplatin, 1.0mg/ml:
240 | Same |
| | Cyclophosphamide
(Cytoxan), 20.0mg/ml:
240 | Cyclophosphamide
(Cytoxan), 20.0mg/ml:
240 | Same |
| | Dacarbazine,
10.0mg/ml: >240 | Dacarbazine,
10.0mg/ml: >240 | Same |
| | Doxorubicin HCI,
2.0mg/ml: >240 | Doxorubicin HCI,
2.0mg/ml: >240 | Same |
| | Etoposide, 20.0mg/ml:
240 | Etoposide, 20.0mg/ml:
240 | Same |
| | Fluorouracil,
50.0mg/ml: >240 | Fluorouracil,
50.0mg/ml: >240 | Same |
| | Ifosfamide,
50.0mg/ml: >240 | Ifosfamide, 50.0mg/ml:
240 | Same |
| | Methotrexate,
25.0mg/ml: >240 | Methotrexate,
25.0mg/ml: Not tested | Additional test for
subject device |
| | Mitomycin C,
0.5mg/ml: >240 | Mitomycin C, 0.5mg/ml:
Not tested | Additional test for
subject device |
| | Paclitaxel, 6.0mg/ml:
240 | Paclitaxel, 6.0mg/ml:
240 | Same |
| | ThioTepa, 10.0mg/ml:
35.7 | ThioTepa, 10.0mg/ml:
48.3 | 240 | Vincristine Sulfate,
1.0mg/ml: >240 | Same |
| | Mitoxantrone,
2.0mg/ml: Not tested | Mitoxantrone,
2.0mg/ml: >240 | Not to be claimed |
| Biocompatibility
ISO 10993-10
Biological Evaluation
of Medical Devices -
Part 10: Tests for
Irritation and Skin
Sensitization | Under the conditions
of the study, not an
irritant and not a skin
sensitizer | Under the conditions of
the study, not primary
skin irritant;
Under the conditions of
the study, not a contact
sensitizer | Similar |
| Biocompatibility
ISO 10993-11
Biological Evaluation of
Medical Devices- Part
11: Tests for Systemic
Toxicity | Under the conditions
of the study, the test
article is considered
non-toxic | The test article was
considered non-toxic | Similar |
Table 1: Comparison to Predicate Device for both Device Candidate #1 and Device Candidate #2:
6
7
8. Summary of Non-Clinical Tests Performed for Determination of Substantial Equivalence for both Device Candidate #1 and Device Candidate #2 are as follows:
| Table 2: Summary Non-Clinical Tests | ||
|---|---|---|
| Standard | Testing | Requirements are met |
| ASTM | ||
| D5151 | Watertight Test | |
| (Freedom from | ||
| Holes) | Pass Inspection Level G1, AQL 2.5 | |
| ASTM | ||
| D6319 | Dimensions | Length |
| XS: min 220mm | ||
| S: min 220mm | ||
| M: min 230mm | ||
| L: min 230mm | ||
| XL: min 230mm | ||
| XXL: min 230mm | ||
| Palm Width | ||
| XS: 70 ± 10mm | ||
| S: 80 ± 10mm | ||
| M: 95 ± 10mm | ||
| L: 110 ± 10mm | ||
| XL: 120 ± 10mm | ||
| XXL: 130 ± 10mm | ||
| Thickness | ||
| Finger: min 0.05mm | ||
| Palm: min 0.05mm | ||
| ASTM | Physical | Before Aging: |
Table 2: Summary Non-Clinical Tests
T
8
| D6319 | Properties | Tensile strength: min 14MPa
Ultimate elongation: min 500% |
|---------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | After Aging:
Tensile strength: min 14MPa
Ultimate elongation: min 400% |
| ASTM
D6124 | Powder Amount | Residual powder