(87 days)
Not Found
No
The device is a physical examination glove and the summary does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which serves a barrier function rather than treating or curing a medical condition.
No
The device is a non-sterile disposable examination glove intended for medical purposes to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of synthetic copolymer, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for protection, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a medical condition.
- Device Description: The description confirms it's a glove made of synthetic material for single use.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. The testing mentioned (chemotherapy drug resistance, physical properties, biocompatibility) is relevant to the glove's barrier function and safety, not to in vitro diagnostic testing.
Therefore, based on the provided information, this device is a medical glove, not an IVD.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine (BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL,(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/ m ),(1,000 ppm) | >240 |
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
| Fentanyl in Gastric Acid | 50/50 Mix | >240 |
| Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa |
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO
Device Description
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
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)
Non-Clinical Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:
ASTM D6319-10 Standard D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in Medical Gloves
ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves
ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Key results from the comparison table:
- All sizes comply with length dimensions for overall length, width (mean), and palm & finger thickness.
- Tensile strength complies both before and after accelerated aging.
- Ultimate elongation complies both before and after accelerated aging.
- Freedom from holes: Pass
- Powder-Free: Less than 2.0mg per glove; Pass
- Biocompatibility (ISO 10993-11 Systemic Toxicity Test): Under conditions of the study, the device extracts did not elicit a systemic response in the model animal.
- Biocompatibility (ISO 10993-10 Primary Skin Irritation on Rabbits): Under conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model.
- Biocompatibility (ISO 10993-10 Magnusson & Kligman Guinea pig Maximization): Under conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
April 10, 2020
Kimberly-Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075
Re: K200072
Trade/Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, Simulated Gastric acid, and Fentanyl in Simulated Gastric acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: January 15, 2020 Received: January 16, 2020
Dear Wava Truscott:
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/cfpmp/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 mediation-emitting products, including information about labeling regulations, please see Device (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,
David Krause
for CAPT 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) K200072
Device Name
KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentany1 Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Indications for Use (Describe)
The Nittile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine (BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL,(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/ m ),(1,000 ppm) | >240 |
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
| Fentanyl in Gastric Acid | 50/50 Mix | >240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa
3
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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4
The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).
510(k) Number: K200072
Preparation Date: April 6, 2020 510(k) Summary
KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
1. Submitter:
| Company Name:
Address:
Country:
Phone: | Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076
United States of America
+1 770 587 8000 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Juan M. Marquez
Director, Regulatory Affairs
Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 |
| Phone | +1 678-352-6069 |
| Fax | +1920-969-4863 |
| E-mail: | Juan.M.Marquez@kcc.com |
2. Correspondent:
| Correspondent: | Wava Truscott, PhD. |
|---|---|
| Company Name: | Truscott MedSci Associates, LLC |
| Address: | 180 Burkemeade Ct. |
| Roswell, GA 30075 | |
| Phone: | +1 (678) 860-1550 |
| Fax: | +1 (770) 552-2887 |
| Email: | Wava.Truscott@gmail.com |
3. Device information:
| Device Trade Name: | KIMTECH™ Purple Nitrile™ Powder free Examination Gloves Tested for
Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric
Acid, and Fentanyl in Simulated Gastric Acid |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Patient Examination Glove |
| Classification: | Class I (general controls) |
| Regulation Number: | 21 CFR 880-6250 |
| Common name: | Powder-free Nitrile Exam Glove for use with Chemotherapy drugs and
Fentanyl |
| Product Code: | LZC, LZA, QDO |
5
4. Predicate Device:
K170686: Brightway Non-Powdered Nitrile Examination Glove Tested for use with Chemotherapy gloves: LZA, LZC (Subject Glove is exactly the same glove, but seeking the additional QDO claim)
K182241: Non-Sterile Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy gloves: LZA, LZC, QDO
5. Description of the Device:
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
6. Indications for Use:
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine(BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL),(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/m),(1,000 ppm) | >240 |
| Fentanyl Opioid and Gastric acid tested as follows: | ||
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
6
Fentanyl in Gastric Acid 50/50 Mix >240 Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa
| Attributes | Standard
Where Test
Sets Limits | a) Predicate
Device:
K182241 | b) Predicate
Device: K170686 | Subject Device Glove | How Does Subject
Glove Compare to
Predicates |
|---------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name
of Device Type | NA | Examination
Glove | Examination
Glove | Examination
Glove | a) Same
b) Same |
| Base Material | NA | Nitrile | Nitrile | Nitrile | c) Same
d) Same |
| Color | NA | Black | Purple | Purple | a) Different than
K182241; but,
biocompatibility, &
physical attributes,
show difference in
color has not
altered glove safety
or performance
b) Identical to
K170686 |
| Glove
formulation | NA | Owners own
proprietary
formula | KC Purple Nitrile
9.5 Chemo
Formulation | KC Purple Nitrile
9.5 Chemo
Formulation | a) Different than
K182241, actual
formula unknown
b) Identical to
K170686 |
| Product Codes | NA | LZA, LZC, QDO | LZA, LZC | LZA, LZC, QDO | a) Same
b) Similar-no QDO |
| Sterile vs Non-
Sterile | NA | Non-Sterile | Non-Sterile | Non-Sterile | a) Same
b) Same |
| Prescription or
OTC | NA | OTC | OTC | OTC | a) Same
b) Same |
| Attributes | Standard
Where
Limits
Test
Limits Set | a) Predicate
Device: K182241 | b) Predicate
Device: K170686 | Subject Device
Glove | How Does
Subject Glove
Compare to
Predicates |
| Single Use-
Disposable | NA | Yes | Yes | Yes | a) Same
b) Same |
| Intended Use | NA | The device 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. | The device 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. | The device 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) Same
b) Same |
| Indications for
use (summary) | NA | In addition to
routine
examination
glove's intended
use, the Subject
Glove was Tested
for use with
chemotherapy
drugs and the
opioid Fentanyl
SEE Below for
specifics | In addition to
routine
examination
glove's intended
use, the Subject
Glove was Tested
for use with
Chemotherapy
drugs
SEE Below for
specifics | KIMTECHTM
Purple NitrileTM
Powder Free
Examination
Gloves Tested for
Use with
Chemotherapy
Drugs, the
Fentanyl Citrate,
Gastric acid, and
Fentanyl in
Gastric acid
SEE Below for
specifics | a) Similar: Both
tested with
Chemotherapy drugs
but some drugs
different. Both also
tested for Fentanyl,
but Subject glove
also tested with
gastric acid and
Fentanyl in gastric
acid
b) similar: Because
they are same glove,
same Chemo drugs
test breakthrough
times identical to
K170686; because
same test data, but
subject glove also
tested for Fentanyl
citrate, gastric acid,
and Fentanyl in
gastric acid to be
cleared for QDO
claims |
| Attributes | Standard
Tests
Where
Limits Set | a) Predicate
Device: K182241
Chemotherapy
drugs tested: | b) Predicate
Device: K170686
Chemotherapy
drugs tested: | Subject Device Glove
Chemotherapy
drugs tested: | How Does
Subject Glove
Compare to
Predicates |
| Indications
for Use
Claims | ASTM
D6978 -05
Re -
approved
2013 | • Carmustine
(BCN U)
• Cisplatin,
• Cyclophosphamide
(Cytoxan),
• Dacarbazine
(DTIC)
• Doxorubicin
Hydrochloride,
• Etoposide
(Toposar)
• Fluorouracil,
• Methotrexate
• Paclitazel (Taxol),
• Thiotepa
• Vincristine Sulfate
Note Carmustine
(BCN U) and
Thiotepa have
low permeation
times
In Addition:
• Fentanyl | • Blenoxane
• Busulfan
• Carmustine
• Cisplatin
• Cyclophosphamide
/Cytoxan
• Cytarabine
• Dacarbazine
• Daunorubicin
• Docetaxel
• Doxorubicin
• Ellence
• Etoposide/
Toposar
• Fluorouracil
• Gemcitabine
• Idarubicin
• Ifosfamide
• Mechlorethamine HCL
• Melphalan
• Methotrexate
• Mitomycin C
• Mitoxantrone
• Paclitaxel
• Paraplatin
• Rituxmab
• Thiotepa
• Trisenox
• Vincristine Sulfate
All >240min except
ThioTEPA;
Ca1mustine | • Blenoxane
• Busulfan
• Carmustine
• Cisplatin
• Cyclophosphamide
/Cytoxan
• Cytarabine
• Dacarbazine
• Daunorubicin
• Docetaxel
• Doxorubicin
• Ellence
• Etoposide/
Toposar
• Fluorouracil
• Gemcitabine
• Idarubicin
• Ifosfamide
• Mechlorethamine HCL
• Melphalan
• Methotrexate
• Mitomycin C
• Mitoxantrone
• Paclitaxel
• Paraplatin
• Rituximab
• Thiotepa
• Trisenox
• Vincristine Sulfate
All >240min except
ThioTEPA; Carmustine
• Fentanyl Citrate
• Gastric acid
• Fentanyl Citrate in
Gastric acid | a) Similar: both
tested CHEMO
Drugs for
pem1eation, but
Subject glove
tested more. Both
tested Fentanyl, but
Subject glove also
tested Gastricacid
b) Similar: The
subject glove has
listed the same
29
Chemotherapy
drugs as (b) because
same glove and
the data from
K170686 used for
Subject glove data
submission, but the
glove has now also
be e n tested with
additional Fentanyl
and Gastric Acid to
acquire the QDO
code. |
| Attributes | Standard
Where Limits
Test
Limits Set | a) Predicate Device:
K182241 | b) Predicate Device:
K170686 | Subject Device Glove | How Does Subject
Glove Compare to
Predicates |
| Caution/
Warning
Statements | NA | Note Carmustine
(BCNU) and
Thiotepa have
low permeation
times | Note: Carmustine
and Thiotepa
have extremely
low permeation
times of 3.6 and
15.9 minutes
respectively.
WARNING:
Not for use
with:
Carmustine,
Thiotepa | Note: Carmustine
and Thiotepa
have extremely
low permeation
times of 3.6 and
15.9 minutes
respectively.
WARNING:
Not for Use With:
Carmustine,
Thiotepa | a) Similar:
Predicate
K182241 does
not list the
breakthrough
times in the
"Note," nor does
it instruct wearer
not to use with
Carmustine,
Thiotepa. Subject
Glove is more
informative
b) Same |
| Dimensions:
Overall length | ASTM D6319
Minimum:
230mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Dimensions:
Width (mean) | ASTM D6319
Minimum: 70
+
10mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Dimensions:
Palm & Finger
Thickness | ASTM D6319
Min.Palm:
0.05mm
Finger:
0.05mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Tensile
strength:
Before &
After Aging | ASTM D6319
Min Before:
14MPa
After: 14Mpa | Complies both
before and after
accelerated aging | Complies both
before and after
accelerated aging | Complies both
before and after
accelerated aging | Same |
| Attributes | Standard Where
Limits Test
Limits Set | a) Predicate Dev
ice: K182241 | b) Predicate Device:
K170686 | Subject Device Glove | How Does
Subject Glove
Compare to
Predicates |
| Ultimate
elongation
Before & After
aging | ASTM
D6319
Minimum:
Before: 500%
After:
400% | Complies both
before and after
accelerated aging | Complies both
before and after
accelerated aging | Complies both before
and after accelerated
aging | Same |
| Freedom from
holes: | ASTM
D6319 G1,
AQL 2.5
7 Accept
8 Reject | Pass | Pass | Pass | Same |
| Powder-Free | ASTM
D6319
Maximum